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The three pillars of perinatal care: Babies, parents, dyadic relationships
Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments.
Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.1 Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.
Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.
The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.2
The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
Family research
There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.
Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.
When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.3
A high-quality intimate relationship is protective for many illnesses and PND is no exception.4
Assessment
Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.
The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.5 This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.
- I have been able to laugh and see the funny side of things.
- I have looked forward with enjoyment to things.
- I have blamed myself unnecessarily when things went wrong.
- I have been anxious or worried for no good reason.
- I have felt scared or panicky for no good reason.
- Things have been getting to me.
- I have been so unhappy that I have had difficulty sleeping.
- I have felt sad or miserable.
- I have been so unhappy that I have been crying.
- The thought of harming myself has occurred to me.
A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.6
For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).7
Family therapy interventions
A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.
In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.8
Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:
- Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
- Conflict management.
- Problem-solving skills related to shared responsibility in infant care and household activities.
Intensive day program for mothers and babies
There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.9
The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.
The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.
A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.10
Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.
The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.11
Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.
Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.
3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.
5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.
7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.
8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.
10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.
11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.
Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments.
Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.1 Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.
Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.
The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.2
The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
Family research
There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.
Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.
When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.3
A high-quality intimate relationship is protective for many illnesses and PND is no exception.4
Assessment
Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.
The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.5 This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.
- I have been able to laugh and see the funny side of things.
- I have looked forward with enjoyment to things.
- I have blamed myself unnecessarily when things went wrong.
- I have been anxious or worried for no good reason.
- I have felt scared or panicky for no good reason.
- Things have been getting to me.
- I have been so unhappy that I have had difficulty sleeping.
- I have felt sad or miserable.
- I have been so unhappy that I have been crying.
- The thought of harming myself has occurred to me.
A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.6
For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).7
Family therapy interventions
A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.
In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.8
Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:
- Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
- Conflict management.
- Problem-solving skills related to shared responsibility in infant care and household activities.
Intensive day program for mothers and babies
There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.9
The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.
The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.
A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.10
Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.
The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.11
Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.
Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.
3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.
5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.
7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.
8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.
10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.
11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.
Perinatal depression (PND) is the most common obstetric complication in the United States. Even when screening results are positive, mothers often do not receive further evaluation, and even when PND is diagnosed, mothers do not receive evidence-based treatments.
Meta-analytic estimates show that pregnant women suffer from PND at rates from 6.5% to 12.9% across pregnancy to 3-months post partum.1 Women from low-income families and adolescent mothers are at highest risk, where rates are double and triple respectively.
Fathers also suffer from PND, with a prevalence rate from 2% to 25%, increasing to 50% when the mother experiences PND.
The American Academy of Pediatrics issued a Policy Statement (January 2019) about the need to recognize and manage PND. They recommended that pediatric medical homes establish a system to implement the screening of mothers at the 1-, 2-, 4-, and 6-month well-child visits, to use community resources for the treatment and referral of the mother with depression, and to provide support for the maternal-child relationship.2
The American Academy of Pediatrics also recommends advocacy for workforce development for mental health professionals who care for young children and mother-infant dyads, and for promotion of evidence-based interventions focused on healthy attachment and parent-child relationships.
Family research
There is a bidirectional association between family relational stress and PND. Lack of family support is both a predictor and a consequence of perinatal depression. Frequent arguments, conflict because one or both partners did not want the pregnancy, division of labor, poor support following stressful life events, lack of partner availability, and low intimacy are associated with increased perinatal depressive symptoms.
Gender role stress is also included as a risk factor. For example, men may fear performance failure related to work and sex, and women may fear disruption in the couple relationship due to the introduction of a child.
When depressed and nondepressed women at 2 months post delivery were compared, the women with depressive symptoms perceived that their partners did not share similar interests, provided little companionship, expressed disinterest in infant care, did not provide a feeling of connection, did not encourage them to get assistance to cope with difficulties, and expressed disagreement in infant care.3
A high-quality intimate relationship is protective for many illnesses and PND is no exception.4
Assessment
Despite the availability of effective treatments, perinatal mental health utilization rates are strikingly low. There are limited providers and a general lack of awareness of the need for this care. The stigma for assessing and treating PND is high because the perception is that pregnancy is supposed to be a joyous time and with time, PND will pass.
The first step is a timely and accurate assessment of the mother, which should, if possible, include the father and other family support people. The preferred standard for women is the Edinburgh Postnatal Depression Scale (EPDS), a checklist of 10 items (listed below) with a maximum score of 30, and any score over 10 warrants further assessment.5 This scale is used worldwide in obstetric clinics and has been used to identify PND in fathers.
- I have been able to laugh and see the funny side of things.
- I have looked forward with enjoyment to things.
- I have blamed myself unnecessarily when things went wrong.
- I have been anxious or worried for no good reason.
- I have felt scared or panicky for no good reason.
- Things have been getting to me.
- I have been so unhappy that I have had difficulty sleeping.
- I have felt sad or miserable.
- I have been so unhappy that I have been crying.
- The thought of harming myself has occurred to me.
A new ultrabrief tool with only four questions is the Brief Multidimensional Assessment Scale (BMAS), which measures the ability to get things done, emotional support in important relationships, quality of life, and sense of purpose in life. It demonstrates concurrent validity with other measures and discriminates between nonclinical participants and participants from most clinical contexts.6
For those interested in assessing family health, an easy-to-use assessment tool is the 12-item Family Assessment Device (FAD).7
Family therapy interventions
A systematic review and meta-analysis of the current evidence on the usefulness of family therapy interventions in the prevention and treatment of PND identified seven studies.
In these studies, there were statistically significant reductions in depressive symptoms at postintervention in intervention group mothers. Intervention intensity and level of family involvement moderated the impacts of intervention on maternal depression, and there was a trend in improved family functioning in intervention group couples.8
Evidence-based interventions are usually psychoeducational or cognitive-behavioral family therapy models where focused interventions target the following three areas:
- Communication skills related to expectations (including those that pertain to gender roles and the transition to parenthood) and emotional support.
- Conflict management.
- Problem-solving skills related to shared responsibility in infant care and household activities.
Intensive day program for mothers and babies
There is a growing awareness of the effectiveness of specialized mother-baby day hospital programs for women with psychiatric distress during the peripartum period.9
The Women & Infants’ Hospital (WIH) in Providence, R.I., established a mother-baby postpartum depression day program in 2000, adjacent to the obstetrical hospital, the ninth largest obstetrical service in the United States. The day program is integrated with the hospital’s obstetric medicine team and referrals are also accepted from the perinatal practices in the surrounding community. The treatment day includes group, individual, and milieu treatment, as well as consultation with psychiatrists, nutritionists, social workers, lactation specialists and others.
The primary theoretical model utilized by the program is interpersonal psychotherapy (IPT), with essential elements of the program incorporating cognitive behavioral therapy (CBT), and experiential strategies (for instance, mindfulness, breathing, progressive muscle relaxation) to improve self-care and relaxation skills. Patient satisfaction surveys collected from 800 women, (54% identified as White) treated at the program between 2007 and 2012 found that women were highly satisfied with the treatment received, noting that the inclusion of the baby in their treatment is a highly valued aspect of care.
A similar program in Minnesota reported that 328 women who consented to participation in research had significant improvements (P < .001) in self-report scales assessing depression, anxiety, and maternal functioning, improving mental health and parenting functioning.10
Lastly, a recent study out of Brussels, on the benefit of a mother-baby day program analyzed patient data from 2015 and 2020. This clinical population of 92 patients (43% identifying as North African) was comparable to the population of the inpatient mother-baby units in terms of psychosocial fragility except that the parents entering the day program had less severe illnesses, more anxiety disorder, and less postpartum psychosis. In the day program, all the babies improved in terms of symptoms and relationships, except for those with significant developmental difficulties.
The dyadic relationship was measured using “levels of adaptation of the parent–child relationship” scale which has four general levels of adjustment, from well-adjusted to troubled or dangerous relationship. Unlike programs in the United States, this program takes children up to 2.5 years old and the assessment period is up to 8 weeks.11
Prevention of mental illness is best achieved by reducing the known determinants of illness. For PND, the research is clear, so why not start at the earliest possible stage, when we know that change is possible? Pushing health care systems to change is not easy, but as the research accumulates and the positive results grow, our arguments become stronger.
Dr. Heru is a psychiatrist in Aurora, Colo. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].
References
1. Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
2. Rafferty J et al. Incorporating recognition and management of perinatal depression into pediatric practice. Pediatrics. 2019 Jan;143(1):e20183260. doi: 10.1542/peds.2018-3260.
3. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
4. Kumar SA et al. Promoting resilience to depression among couples during pregnancy: The protective functions of intimate relationship satisfaction and self-compassion. Family Process. 2022 May;62(1):387-405. doi: 10.1111/famp.12788.
5. Cox JL et al. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
6. Keitner GI et al. The Brief Multidimensional Assessment Scale (BMAS): A broad measure of patient well-being. Am J Psychother. 2023 Feb 1;76(2):75-81. doi: 10.1176/appi.psychotherapy.20220032.
7. Boterhoven de Haan KL et al. Reliability and validity of a short version of the general functioning subscale of the McMaster Family Assessment Device. Fam Process. 2015 Mar;54(1):116-23. doi: 10.1111/famp.12113.
8. Cluxton-Keller F, Bruce ML. Clinical effectiveness of family therapeutic interventions in the prevention and treatment of perinatal depression: A systematic review and meta-analysis. PLoS One. 2018 Jun 14;13(6):e0198730. doi: 10.1371/journal.pone.0198730.
9. Battle CL, Howard MM. A mother-baby psychiatric day hospital: History, rationale, and why perinatal mental health is important for obstetric medicine. Obstet Med. 2014 Jun;7(2):66-70. doi: 10.1177/1753495X13514402.
10. Kim HG et al. Keeping Parent, Child, and Relationship in Mind: Clinical Effectiveness of a Trauma-informed, Multigenerational, Attachment-Based, Mother-Baby Partial Hospital Program in an Urban Safety Net Hospital. Matern Child Health J. 2021 Nov;25(11):1776-86. doi: 10.1007/s10995-021-03221-4.
11. Moureau A et al. A 5 years’ experience of a parent-baby day unit: impact on baby’s development. Front Psychiatry. 2023 June 15;14. doi: 10.3389/fpsyt.2023.1121894.
Telehealth visit helps reconnect adolescents lost to follow-up
A telehealth primary care visit more than doubled the well-visit show rate for a cohort of hard-to-reach adolescents, results of a small pilot study show.
Brian P. Jenssen, MD, MSHP, department of pediatrics, University of Pennsylvania, Philadelphia, led the pilot study and the project team, which included physicians, researchers, and experts in innovation, quality improvement, and data analytics.
Findings were published online in Annals of Family Medicine.
Keeping adolescents in consistent primary care can be challenging for many reasons. The study authors note, “Only 50% of adolescents have had a health supervision visit in the past year, missing a critical opportunity for clinicians to influence health, development, screening, and counseling.”
Interest high in hard-to-reach group
This study included a particularly hard-to-reach group of 18-year-old patients at an urban primary care clinic who were lost to follow-up and had Medicaid insurance. They had not completed a well visit in more than 2 years and had a history of no-show visits.
Interest in the pilot program was high. The authors write: “We contacted patients (or their caregivers) to gauge interest in a virtual well visit with a goal to fill five telehealth slots in one evening block with one clinician. Due to high patient interest and demand, we expanded to 15 slots over three evenings, filling the slots after contacting just 24 patients.”
Professional organizations have recommended a telehealth/in-person hybrid care model to meet hard-to-reach adolescents “wherever they are,” the authors note, but the concept has not been well studied.
Under the hybrid model, the first visit is through telehealth and in-person follow-up is scheduled as needed.
Navigators contacted patients to remind them of the appointment, and helped activate the patient portal and complete previsit screening questions for depression and other health risks.
Telehealth visits were billed as preventive visits and in-person follow-up visits as no-charge nurse visits, and these payments were supported by Medicaid.
Sharp increase in show rate
In the pilot study, of the 15 patients scheduled for the telehealth visit, 11 connected virtually (73% show rate). Of those, nine needed in-person follow-up, and five completed the follow-up.
Before the intervention, the average well-visit show rate for this patient group was 33%.
Clinicians counseled all the patients about substance use and safe sex. One patient screened positive for depression and was then connected to services. Two patients were started on birth control.
During the in-person follow-up, all patients received vaccinations (influenza, meningococcal, and/or COVID-19) and were screened for sexually transmitted infection. Eight patients completed the satisfaction survey and all said they liked the convenience of the telehealth visit.
Telehealth may reduce barriers for teens
Anthony Cheng, MD, a family medicine physician at Oregon Health & Science University in Portland, who was not part of the study, said he found the hybrid model promising.
One reason is that telehealth eliminates the need for transportation to medical appointments, which can be a barrier for adolescents.
Among the top causes of death for young people are mental health issues and addressing those, Dr. Cheng noted, is well-suited to a telehealth visit.
“There’s so much we can do if we can establish a relationship and maintain a relationship with our patients as young adults,” he said. “People do better when they have a regular source of care.”
He added that adolescents also have grown up communicating via screens so it’s often more comfortable for them to communicate with health care providers this way.
Dr. Cheng said adopting such a model may be difficult for providers reluctant to switch from the practice model with which they are most comfortable.
“We prefer to do things we have the most confidence in,” he said. “It does take an investment to train staff and build your own clinical comfort. If that experience wasn’t good over the past 3 years, you may be anxious to get back to your normal way of doing business.”
The authors and Dr. Cheng have no relevant financial relationships to disclose.
A telehealth primary care visit more than doubled the well-visit show rate for a cohort of hard-to-reach adolescents, results of a small pilot study show.
Brian P. Jenssen, MD, MSHP, department of pediatrics, University of Pennsylvania, Philadelphia, led the pilot study and the project team, which included physicians, researchers, and experts in innovation, quality improvement, and data analytics.
Findings were published online in Annals of Family Medicine.
Keeping adolescents in consistent primary care can be challenging for many reasons. The study authors note, “Only 50% of adolescents have had a health supervision visit in the past year, missing a critical opportunity for clinicians to influence health, development, screening, and counseling.”
Interest high in hard-to-reach group
This study included a particularly hard-to-reach group of 18-year-old patients at an urban primary care clinic who were lost to follow-up and had Medicaid insurance. They had not completed a well visit in more than 2 years and had a history of no-show visits.
Interest in the pilot program was high. The authors write: “We contacted patients (or their caregivers) to gauge interest in a virtual well visit with a goal to fill five telehealth slots in one evening block with one clinician. Due to high patient interest and demand, we expanded to 15 slots over three evenings, filling the slots after contacting just 24 patients.”
Professional organizations have recommended a telehealth/in-person hybrid care model to meet hard-to-reach adolescents “wherever they are,” the authors note, but the concept has not been well studied.
Under the hybrid model, the first visit is through telehealth and in-person follow-up is scheduled as needed.
Navigators contacted patients to remind them of the appointment, and helped activate the patient portal and complete previsit screening questions for depression and other health risks.
Telehealth visits were billed as preventive visits and in-person follow-up visits as no-charge nurse visits, and these payments were supported by Medicaid.
Sharp increase in show rate
In the pilot study, of the 15 patients scheduled for the telehealth visit, 11 connected virtually (73% show rate). Of those, nine needed in-person follow-up, and five completed the follow-up.
Before the intervention, the average well-visit show rate for this patient group was 33%.
Clinicians counseled all the patients about substance use and safe sex. One patient screened positive for depression and was then connected to services. Two patients were started on birth control.
During the in-person follow-up, all patients received vaccinations (influenza, meningococcal, and/or COVID-19) and were screened for sexually transmitted infection. Eight patients completed the satisfaction survey and all said they liked the convenience of the telehealth visit.
Telehealth may reduce barriers for teens
Anthony Cheng, MD, a family medicine physician at Oregon Health & Science University in Portland, who was not part of the study, said he found the hybrid model promising.
One reason is that telehealth eliminates the need for transportation to medical appointments, which can be a barrier for adolescents.
Among the top causes of death for young people are mental health issues and addressing those, Dr. Cheng noted, is well-suited to a telehealth visit.
“There’s so much we can do if we can establish a relationship and maintain a relationship with our patients as young adults,” he said. “People do better when they have a regular source of care.”
He added that adolescents also have grown up communicating via screens so it’s often more comfortable for them to communicate with health care providers this way.
Dr. Cheng said adopting such a model may be difficult for providers reluctant to switch from the practice model with which they are most comfortable.
“We prefer to do things we have the most confidence in,” he said. “It does take an investment to train staff and build your own clinical comfort. If that experience wasn’t good over the past 3 years, you may be anxious to get back to your normal way of doing business.”
The authors and Dr. Cheng have no relevant financial relationships to disclose.
A telehealth primary care visit more than doubled the well-visit show rate for a cohort of hard-to-reach adolescents, results of a small pilot study show.
Brian P. Jenssen, MD, MSHP, department of pediatrics, University of Pennsylvania, Philadelphia, led the pilot study and the project team, which included physicians, researchers, and experts in innovation, quality improvement, and data analytics.
Findings were published online in Annals of Family Medicine.
Keeping adolescents in consistent primary care can be challenging for many reasons. The study authors note, “Only 50% of adolescents have had a health supervision visit in the past year, missing a critical opportunity for clinicians to influence health, development, screening, and counseling.”
Interest high in hard-to-reach group
This study included a particularly hard-to-reach group of 18-year-old patients at an urban primary care clinic who were lost to follow-up and had Medicaid insurance. They had not completed a well visit in more than 2 years and had a history of no-show visits.
Interest in the pilot program was high. The authors write: “We contacted patients (or their caregivers) to gauge interest in a virtual well visit with a goal to fill five telehealth slots in one evening block with one clinician. Due to high patient interest and demand, we expanded to 15 slots over three evenings, filling the slots after contacting just 24 patients.”
Professional organizations have recommended a telehealth/in-person hybrid care model to meet hard-to-reach adolescents “wherever they are,” the authors note, but the concept has not been well studied.
Under the hybrid model, the first visit is through telehealth and in-person follow-up is scheduled as needed.
Navigators contacted patients to remind them of the appointment, and helped activate the patient portal and complete previsit screening questions for depression and other health risks.
Telehealth visits were billed as preventive visits and in-person follow-up visits as no-charge nurse visits, and these payments were supported by Medicaid.
Sharp increase in show rate
In the pilot study, of the 15 patients scheduled for the telehealth visit, 11 connected virtually (73% show rate). Of those, nine needed in-person follow-up, and five completed the follow-up.
Before the intervention, the average well-visit show rate for this patient group was 33%.
Clinicians counseled all the patients about substance use and safe sex. One patient screened positive for depression and was then connected to services. Two patients were started on birth control.
During the in-person follow-up, all patients received vaccinations (influenza, meningococcal, and/or COVID-19) and were screened for sexually transmitted infection. Eight patients completed the satisfaction survey and all said they liked the convenience of the telehealth visit.
Telehealth may reduce barriers for teens
Anthony Cheng, MD, a family medicine physician at Oregon Health & Science University in Portland, who was not part of the study, said he found the hybrid model promising.
One reason is that telehealth eliminates the need for transportation to medical appointments, which can be a barrier for adolescents.
Among the top causes of death for young people are mental health issues and addressing those, Dr. Cheng noted, is well-suited to a telehealth visit.
“There’s so much we can do if we can establish a relationship and maintain a relationship with our patients as young adults,” he said. “People do better when they have a regular source of care.”
He added that adolescents also have grown up communicating via screens so it’s often more comfortable for them to communicate with health care providers this way.
Dr. Cheng said adopting such a model may be difficult for providers reluctant to switch from the practice model with which they are most comfortable.
“We prefer to do things we have the most confidence in,” he said. “It does take an investment to train staff and build your own clinical comfort. If that experience wasn’t good over the past 3 years, you may be anxious to get back to your normal way of doing business.”
The authors and Dr. Cheng have no relevant financial relationships to disclose.
FROM ANNALS OF INTERNAL MEDICINE
Zuranolone: A novel postpartum depression treatment, with lingering questions
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that , along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression risk increased among sexual minority women
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
FROM JAMA PSYCHIATRY
Controversial issue of maintenance therapy for bipolar depression still unresolved
Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.
However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.
“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.
The study was published online in the New England Journal of Medicine.
Controversial issue
Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.
Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.
Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.
Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.
The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.
The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.
At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.
The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).
The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.
“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.
However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.
“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.
“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.
Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).
The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.
The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.
Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.
Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability.
In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
Need for an individualized approach
Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.
“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.
“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.
“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”
Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”
“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.
“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.
The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.
A version of this article first appeared on Medscape.com.
Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.
However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.
“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.
The study was published online in the New England Journal of Medicine.
Controversial issue
Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.
Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.
Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.
Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.
The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.
The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.
At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.
The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).
The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.
“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.
However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.
“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.
“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.
Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).
The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.
The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.
Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.
Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability.
In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
Need for an individualized approach
Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.
“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.
“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.
“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”
Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”
“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.
“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.
The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.
A version of this article first appeared on Medscape.com.
Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.
However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.
“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.
The study was published online in the New England Journal of Medicine.
Controversial issue
Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.
Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.
Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.
Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.
The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.
The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.
At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.
The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).
The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.
“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.
However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.
“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.
“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.
Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).
The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.
The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.
Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.
Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability.
In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
Need for an individualized approach
Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.
“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.
“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.
“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”
Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”
“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.
“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.
The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.
A version of this article first appeared on Medscape.com.
FROM NEW ENGLAND JOURNAL OF MEDICINE
A better way to measure antidepressant response?
Investigators assessed more than 800 patients with major depressive disorder (MDD) attending a partial hospital program. The patients completed questionnaires about depressive symptoms as well as functioning and broader measures of quality of life (QoL).
Although fewer than 40% were classified as treatment responders on the basis of depressive symptoms, as measured by the Remission from Depression Questionnaire (RDQ), two-thirds met criteria as responders on the Patient Global Rating of Improvement (PGI) scale, which takes into consideration broader domains of life satisfaction.
“The treatments we’re offering patients may be doing a better job than we think in treating depression, because many patients say they feel significantly better, even if their depression symptoms haven’t been diminished by the arbitrary threshold of 50% or greater improvement,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., told this news organization.
“Many of these patients – even if they have ongoing depressive symptoms – nevertheless say treatment has been very or extremely helpful, which is picked by other emphasizes in outcome, such as functioning, quality of life, coping abilities, and positive mental health,” added Dr. Zimmerman, director of the outpatient division at the Partial Hospital Program, Rhode Island Hospital.
The study was published online in the Annals of Clinical Psychiatry.
What’s the best tool?
“Almost all studies of depression treatment rely on measures of symptom severity to evaluate outcome – which is understandable, because a diagnosis of MDD requires a minimum number of symptoms for a sustained period of time,” said Dr. Zimmerman.
However, while important, symptom reduction is only one component of depression treatment. Improving overall function, QoL, and ability to deal with life’s stressors are equally important, he said.
Dr. Zimmerman emphasized he’s an “advocate, supporter, and practitioner of measurement-based care.” This approach, he said, “increases efficiency of the visit and directs me to the areas I should be inquiring about and the areas that need less time for inquiry.”
Measurement tools also enable numerical documentation of how a patient is doing and helps them understand and recognize their improvement.
The question is which tool captures improvements most effectively. Several surveys show that patients value improved functioning and QoL as primary treatment goals, which “is different from the emphasis of symptom improvement found in research,” said Dr. Zimmerman.
A multidimensional questionnaire that assesses functioning, QoL, and coping ability as well as symptoms is more likely to reflect patients’ treatment goals than simply measuring symptoms, he said.
Dr. Zimmerman and his coauthor reported on findings from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, which “examined the concordance between patients’ global rating of improvement from treatment and responder status, based on a depression symptoms severity scale.”
Doing better than we think
The study was conducted in Rhode Island Hospital’s department of psychiatry partial hospital program, where 844 patients with MDD (65.2% women; mean [SD] age, 36.8 [13.9] years) completed the RDQ – a self-report measure that “assesses constructs that patients consider to be relevant for assessing treatment outcome.” This questionnaire assesses symptom and nonsymptom domains that people consider important when evaluating treatment effectiveness.
To the original 41-item questionnaire, the researchers added 19 items. The final 60-item questionnaire included the following:
- 14 depressive symptoms.
- 11 nondepressive symptoms.
- 5 coping ability/stress tolerance items (for instance, “I had trouble handling pressure”).
- 12 positive mental health items (for instance, “I saw myself as a person of value”).
- 10 functioning items (for instance, “I was socially withdrawn”).
- 8 general well-being/life satisfaction items (for instance, “I was engaging in life rather than hiding from it”).
Patients were divided into three groups:
- Symptom responders (whose scores on the RDQ depressive symptom subscale improved by ≥ 50% from admission to discharge).
- PGI responders, who weren’t symptom responders – that is, who reported global improvement but didn’t improve ≥ 50% on the depression symptom subscale.
- Nonresponders (that is, patients who didn’t respond on the PGI and the depressive symptom subscale).
The researchers compared the three groups on the four symptom domains of the RDQ. Patients also completed the PGI on discharge, and the researchers compared these responses to responses to the RDQ.
Only 38.7% were responders on the depressive symptoms subscale, while 67.4% were PGI responders.
Most patients (91.4%) who were responders on the depressive symptom subscale were also PGI responders, while 32% were PGI responders but not responders on the depressive symptom subscale.
Although 29.2% were nonresponders on both measures, 70.8% were responders on one scale or the other.
As far as the nonsymptom domains, response rates varied between 30% (life satisfaction) to 33.1% (positive mental health).
“If you’re using a measurement tool in practice, I’d recommend one that goes beyond symptom improvement and also captures broader domains,” Dr. Zimmerman said.
‘Better enough’
Commenting on the study, Philip Muskin, MD, professor of psychiatry, Columbia University Medical Center, New York, said the use of symptom-driven rating scales to measure depression response originated in mandates of the U.S. Food and Drug Administration to determine whether a drug being tested in a clinical trial is superior to placebo.
“But there has been, for a long time, the question of whether these people are really better,” said Dr. Muskin, who was not involved with the current study. “Symptomatically, they may show improvement, but do they actually perceive themselves as better?”
Some patients might report, “I’m about 75% myself, but not back to 100%.” Dr. Muskin doesn’t “take these to be hard-and-fast numbers, but patients can tell you how they perceive themselves. This study suggests that if you’re wedded to [symptom measurement] scales, you may not realize that patients are actually getting better. And who decides if a patient is better, or better enough? The patient decides that.”
He added that some patients won’t achieve complete remission. “Even if I can’t get the person to be 100% better, I’m glad if I can help them become ‘better enough’ to function in life, do things, go to work, and improve in quality-of-life domains.”
The study received no outside funding. Dr. Zimmerman and his coauthor and Dr. Muskin report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators assessed more than 800 patients with major depressive disorder (MDD) attending a partial hospital program. The patients completed questionnaires about depressive symptoms as well as functioning and broader measures of quality of life (QoL).
Although fewer than 40% were classified as treatment responders on the basis of depressive symptoms, as measured by the Remission from Depression Questionnaire (RDQ), two-thirds met criteria as responders on the Patient Global Rating of Improvement (PGI) scale, which takes into consideration broader domains of life satisfaction.
“The treatments we’re offering patients may be doing a better job than we think in treating depression, because many patients say they feel significantly better, even if their depression symptoms haven’t been diminished by the arbitrary threshold of 50% or greater improvement,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., told this news organization.
“Many of these patients – even if they have ongoing depressive symptoms – nevertheless say treatment has been very or extremely helpful, which is picked by other emphasizes in outcome, such as functioning, quality of life, coping abilities, and positive mental health,” added Dr. Zimmerman, director of the outpatient division at the Partial Hospital Program, Rhode Island Hospital.
The study was published online in the Annals of Clinical Psychiatry.
What’s the best tool?
“Almost all studies of depression treatment rely on measures of symptom severity to evaluate outcome – which is understandable, because a diagnosis of MDD requires a minimum number of symptoms for a sustained period of time,” said Dr. Zimmerman.
However, while important, symptom reduction is only one component of depression treatment. Improving overall function, QoL, and ability to deal with life’s stressors are equally important, he said.
Dr. Zimmerman emphasized he’s an “advocate, supporter, and practitioner of measurement-based care.” This approach, he said, “increases efficiency of the visit and directs me to the areas I should be inquiring about and the areas that need less time for inquiry.”
Measurement tools also enable numerical documentation of how a patient is doing and helps them understand and recognize their improvement.
The question is which tool captures improvements most effectively. Several surveys show that patients value improved functioning and QoL as primary treatment goals, which “is different from the emphasis of symptom improvement found in research,” said Dr. Zimmerman.
A multidimensional questionnaire that assesses functioning, QoL, and coping ability as well as symptoms is more likely to reflect patients’ treatment goals than simply measuring symptoms, he said.
Dr. Zimmerman and his coauthor reported on findings from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, which “examined the concordance between patients’ global rating of improvement from treatment and responder status, based on a depression symptoms severity scale.”
Doing better than we think
The study was conducted in Rhode Island Hospital’s department of psychiatry partial hospital program, where 844 patients with MDD (65.2% women; mean [SD] age, 36.8 [13.9] years) completed the RDQ – a self-report measure that “assesses constructs that patients consider to be relevant for assessing treatment outcome.” This questionnaire assesses symptom and nonsymptom domains that people consider important when evaluating treatment effectiveness.
To the original 41-item questionnaire, the researchers added 19 items. The final 60-item questionnaire included the following:
- 14 depressive symptoms.
- 11 nondepressive symptoms.
- 5 coping ability/stress tolerance items (for instance, “I had trouble handling pressure”).
- 12 positive mental health items (for instance, “I saw myself as a person of value”).
- 10 functioning items (for instance, “I was socially withdrawn”).
- 8 general well-being/life satisfaction items (for instance, “I was engaging in life rather than hiding from it”).
Patients were divided into three groups:
- Symptom responders (whose scores on the RDQ depressive symptom subscale improved by ≥ 50% from admission to discharge).
- PGI responders, who weren’t symptom responders – that is, who reported global improvement but didn’t improve ≥ 50% on the depression symptom subscale.
- Nonresponders (that is, patients who didn’t respond on the PGI and the depressive symptom subscale).
The researchers compared the three groups on the four symptom domains of the RDQ. Patients also completed the PGI on discharge, and the researchers compared these responses to responses to the RDQ.
Only 38.7% were responders on the depressive symptoms subscale, while 67.4% were PGI responders.
Most patients (91.4%) who were responders on the depressive symptom subscale were also PGI responders, while 32% were PGI responders but not responders on the depressive symptom subscale.
Although 29.2% were nonresponders on both measures, 70.8% were responders on one scale or the other.
As far as the nonsymptom domains, response rates varied between 30% (life satisfaction) to 33.1% (positive mental health).
“If you’re using a measurement tool in practice, I’d recommend one that goes beyond symptom improvement and also captures broader domains,” Dr. Zimmerman said.
‘Better enough’
Commenting on the study, Philip Muskin, MD, professor of psychiatry, Columbia University Medical Center, New York, said the use of symptom-driven rating scales to measure depression response originated in mandates of the U.S. Food and Drug Administration to determine whether a drug being tested in a clinical trial is superior to placebo.
“But there has been, for a long time, the question of whether these people are really better,” said Dr. Muskin, who was not involved with the current study. “Symptomatically, they may show improvement, but do they actually perceive themselves as better?”
Some patients might report, “I’m about 75% myself, but not back to 100%.” Dr. Muskin doesn’t “take these to be hard-and-fast numbers, but patients can tell you how they perceive themselves. This study suggests that if you’re wedded to [symptom measurement] scales, you may not realize that patients are actually getting better. And who decides if a patient is better, or better enough? The patient decides that.”
He added that some patients won’t achieve complete remission. “Even if I can’t get the person to be 100% better, I’m glad if I can help them become ‘better enough’ to function in life, do things, go to work, and improve in quality-of-life domains.”
The study received no outside funding. Dr. Zimmerman and his coauthor and Dr. Muskin report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators assessed more than 800 patients with major depressive disorder (MDD) attending a partial hospital program. The patients completed questionnaires about depressive symptoms as well as functioning and broader measures of quality of life (QoL).
Although fewer than 40% were classified as treatment responders on the basis of depressive symptoms, as measured by the Remission from Depression Questionnaire (RDQ), two-thirds met criteria as responders on the Patient Global Rating of Improvement (PGI) scale, which takes into consideration broader domains of life satisfaction.
“The treatments we’re offering patients may be doing a better job than we think in treating depression, because many patients say they feel significantly better, even if their depression symptoms haven’t been diminished by the arbitrary threshold of 50% or greater improvement,” study investigator Mark Zimmerman, MD, professor of psychiatry and human behavior, Brown University, Providence, R.I., told this news organization.
“Many of these patients – even if they have ongoing depressive symptoms – nevertheless say treatment has been very or extremely helpful, which is picked by other emphasizes in outcome, such as functioning, quality of life, coping abilities, and positive mental health,” added Dr. Zimmerman, director of the outpatient division at the Partial Hospital Program, Rhode Island Hospital.
The study was published online in the Annals of Clinical Psychiatry.
What’s the best tool?
“Almost all studies of depression treatment rely on measures of symptom severity to evaluate outcome – which is understandable, because a diagnosis of MDD requires a minimum number of symptoms for a sustained period of time,” said Dr. Zimmerman.
However, while important, symptom reduction is only one component of depression treatment. Improving overall function, QoL, and ability to deal with life’s stressors are equally important, he said.
Dr. Zimmerman emphasized he’s an “advocate, supporter, and practitioner of measurement-based care.” This approach, he said, “increases efficiency of the visit and directs me to the areas I should be inquiring about and the areas that need less time for inquiry.”
Measurement tools also enable numerical documentation of how a patient is doing and helps them understand and recognize their improvement.
The question is which tool captures improvements most effectively. Several surveys show that patients value improved functioning and QoL as primary treatment goals, which “is different from the emphasis of symptom improvement found in research,” said Dr. Zimmerman.
A multidimensional questionnaire that assesses functioning, QoL, and coping ability as well as symptoms is more likely to reflect patients’ treatment goals than simply measuring symptoms, he said.
Dr. Zimmerman and his coauthor reported on findings from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) Project, which “examined the concordance between patients’ global rating of improvement from treatment and responder status, based on a depression symptoms severity scale.”
Doing better than we think
The study was conducted in Rhode Island Hospital’s department of psychiatry partial hospital program, where 844 patients with MDD (65.2% women; mean [SD] age, 36.8 [13.9] years) completed the RDQ – a self-report measure that “assesses constructs that patients consider to be relevant for assessing treatment outcome.” This questionnaire assesses symptom and nonsymptom domains that people consider important when evaluating treatment effectiveness.
To the original 41-item questionnaire, the researchers added 19 items. The final 60-item questionnaire included the following:
- 14 depressive symptoms.
- 11 nondepressive symptoms.
- 5 coping ability/stress tolerance items (for instance, “I had trouble handling pressure”).
- 12 positive mental health items (for instance, “I saw myself as a person of value”).
- 10 functioning items (for instance, “I was socially withdrawn”).
- 8 general well-being/life satisfaction items (for instance, “I was engaging in life rather than hiding from it”).
Patients were divided into three groups:
- Symptom responders (whose scores on the RDQ depressive symptom subscale improved by ≥ 50% from admission to discharge).
- PGI responders, who weren’t symptom responders – that is, who reported global improvement but didn’t improve ≥ 50% on the depression symptom subscale.
- Nonresponders (that is, patients who didn’t respond on the PGI and the depressive symptom subscale).
The researchers compared the three groups on the four symptom domains of the RDQ. Patients also completed the PGI on discharge, and the researchers compared these responses to responses to the RDQ.
Only 38.7% were responders on the depressive symptoms subscale, while 67.4% were PGI responders.
Most patients (91.4%) who were responders on the depressive symptom subscale were also PGI responders, while 32% were PGI responders but not responders on the depressive symptom subscale.
Although 29.2% were nonresponders on both measures, 70.8% were responders on one scale or the other.
As far as the nonsymptom domains, response rates varied between 30% (life satisfaction) to 33.1% (positive mental health).
“If you’re using a measurement tool in practice, I’d recommend one that goes beyond symptom improvement and also captures broader domains,” Dr. Zimmerman said.
‘Better enough’
Commenting on the study, Philip Muskin, MD, professor of psychiatry, Columbia University Medical Center, New York, said the use of symptom-driven rating scales to measure depression response originated in mandates of the U.S. Food and Drug Administration to determine whether a drug being tested in a clinical trial is superior to placebo.
“But there has been, for a long time, the question of whether these people are really better,” said Dr. Muskin, who was not involved with the current study. “Symptomatically, they may show improvement, but do they actually perceive themselves as better?”
Some patients might report, “I’m about 75% myself, but not back to 100%.” Dr. Muskin doesn’t “take these to be hard-and-fast numbers, but patients can tell you how they perceive themselves. This study suggests that if you’re wedded to [symptom measurement] scales, you may not realize that patients are actually getting better. And who decides if a patient is better, or better enough? The patient decides that.”
He added that some patients won’t achieve complete remission. “Even if I can’t get the person to be 100% better, I’m glad if I can help them become ‘better enough’ to function in life, do things, go to work, and improve in quality-of-life domains.”
The study received no outside funding. Dr. Zimmerman and his coauthor and Dr. Muskin report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF CLINICAL PSYCHIATRY
Autism tied to higher rates of self-harm, suicide
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
TOPLINE:
Even after accounting for sociodemographic factors, intellectual disabilities, and psychiatric diagnoses,
METHODOLOGY:
Evidence shows those with autism have over threefold greater odds than their counterparts without the disorder of self-injurious behavior, suicidal ideation, suicide attempt, or suicide death, but reasons for these elevated risks are unclear.
Using various linked databases in the province of Ontario, researchers identified all individuals with an autism diagnosis from April 1, 1988, to March 31, 2018, and matched each on age and sex to four nonautistic individuals for the comparison group.
Investigators created two cohorts to separately evaluate outcomes of self-harm events leading to emergency health care and suicide death with the accrual period for both cohorts beginning at a person’s 10th birthday.
The self-harm cohort included 379,630 individuals while the suicide cohort included 334,690 individuals.
TAKEAWAY:
Over 15 years, autistic females showed the highest cumulative self-harm events, followed by autistic males, nonautistic females, and nonautistic males; over 25 years, autistic males had the highest cumulative incidence of suicide death, followed by autistic females, nonautistic males, and nonautistic females.
Autism had independent associations with self-harm events (females: relative rate, 1.83 [95% confidence interval, 1.61-2.08]; males: RR, 1.47 [95% CI, 1.28-1.69]) even after accounting for sociodemographic factors (varied directions of associations), intellectual disabilities (associated with increased risks), and psychiatric diagnoses including mood and anxiety, psychotic, addiction, and personality disorders (associated with increased risks).
For both females and males, final models showed autism per se was not significantly associated with suicide death, but certain correlates were linked to risk. Among both sexes, intellectual disabilities were associated with reduced risks and psychiatric diagnoses were associated with increased risks.
As a substantial proportion (28.4%) of the suicide cohort did not have data on self-harm, researchers were unable to examine the association of self-harm with suicide death.
IN PRACTICE:
That psychiatric diagnoses increased suicide risks among people with autism suggests supports to reduce such risks “should consider multifactorial mechanisms, with a particular focus on the prevention and timely treatment of psychiatric illnesses,” write the authors.
SOURCE:
The study was conducted by Meng-Chuan Lai, MD, PhD, Centre for Addiction and Mental Health, Toronto, and colleagues. It was published online in JAMA Network Open.
LIMITATIONS:
The autism cohort didn’t capture those diagnosed in private practices or with subtle presentations not yet diagnosed. Misclassification of autistic people in the nonautistic cohort may have resulted in underestimation of suicide-related outcomes. The administrative data don’t reliably identify diagnoses associated with suicide risks such as attention-deficit/hyperactivity disorder or subcategories of mood disorders, and don’t contain information about risk and protective mechanisms of suicide behaviors such as family history.
DISCLOSURES:
The study received support from ICES, an independent nonprofit research institute; the Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario; the Academic Scholars Award from the Department of Psychiatry, University of Toronto; and the Canadian Institutes of Health Research Sex and Gender Science Chair. Dr. Lai reported receiving personal fees from SAGE Publications as an editorial honorarium outside the submitted work. One coauthor reported receiving honoraria from the BMJ Group, Archives of Diseases in Childhood.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Physician-assisted suicide for mental illness – right or wrong?
Until recently, this contentious issue applied only to patients with physical illnesses who want to end their suffering and who seek out a physician willing to assist with that objective. In the United States and other countries, this is the patient population who may be able to avail themselves of this option.
However, newly proposed legislation in Canada – which has the largest number of physician-assisted deaths worldwide – would expand the indication for MAID to include serious mental illness. Originally set to be passed in March 2023, the law has been deferred for final decision until March 2024.
A recent commentary by psychiatrist Dinah Miller, MD, explored the ethics of this proposed legislation for mental health professionals. “To offer the option of death facilitated by the very person who is trying to get [patients with serious mental illness] better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide,” Dr. Miller wrote. “As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it?”
Dr. Miller’s piece garnered a huge amount of reader response that included many laudatory comments: a “nuanced and open-ended inquiry here,” “timely and honest,” and “beautifully written.” One reader thanked the author for “this thoughtful, questioning, and open reflection on what it means to be a psychiatrist facing a thorny and deeply personal practice and philosophical question.”
Cognitive distortion or objective reality?
Many readers were opposed to any type of physician involvement in hastening a patient’s death, regardless of whether the condition is medical or psychiatric. “Let others who wish to die make their own arrangement without the aid of the medical profession,” one reader wrote.
But others felt that for those with terminal physical illnesses or intractable pain, it is justified for medical professionals to either facilitate death or, at the very least, withhold life-prolonging treatments.
A critical-care physician described responding to families’ accusations that withdrawal of life-sustaining measures means “playing God.” On the contrary, the physician wrote, “there is a limit to our abilities; and withdrawing those life-prolonging interventions allows nature or God or whatever to play a role and take its course.”
Another U.S. reader pointed out that “multiple polls in this country have shown that the majority of the general public, physicians in general and psychiatrists in particular, support the option of MAID for the terminally ill. They do not find it at variance with their calling as physicians.”
“I and many of my elderly friends don’t fear death but fear prolonged dementia with its dependency and lack of quality of life,” one reader wrote. “We would be much more at peace if we could put in our advanced directive that we request MAID once some point of dependency has been reached.”
Another wrote that in the event of entering a state of “degrading dependency and hardship on the family, please let me go peacefully, without burdening others, into that good night [of death].”
Many felt that not only physical illness but also the prospect of cognitive degeneration – specifically dementia – also justifies assisting patient death.
“Enormous suffering”
One Canadian reader noted that provisions for advance consent are now in place in Canada for those facing the prospect of neurodegenerative disease and who are still mentally competent to make such decisions.
But therein lies the rub – the concept of an advanced directive goes to the question of decisional capacity. Dr. Miller noted that “depression distorts cognition and leads many patients to believe that they would be better off dead and that their loves ones would be better off without them.”
The concept of “cognitive distortion” implies that the illness itself may impede the decisional capacity required for an advanced directive or a decision made in the moment, in the absence of such a directive. Dr. Miller asked, “How do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?”
One reader attested to this from personal experience. “As both a physician and a sufferer of severe, often profound depression for 50 years, I can confidently say that ... the pursuit of death is the result of an impaired mental state, which simultaneously prevents a rational decision.”
Another agreed. “As a psychiatrist, I treated suicidal patients almost every day of my 27-year career. I believe in making every effort to prevent the suicide of a healthy depressed person and I do not support MAID for psychiatric conditions. But I do support MAID for the terminally ill.”
Other readers disagreed. In the words of one commentator, “I think that if we are going to help mentally ill people, we have to consider their choices. The stress imposed by a severe/intractable mental illness is as bad as any other devastating medical illness. If no one is going to hold their hand in life (as support services are limited and psychiatric treatments often fail), allow a medical professional to hold their hand through their final moments.”
A psychiatrist described very ill patients with treatment-resistant bipolar disorder who had not only received medications, including ketamine, but had also received electroconvulsive therapy and still did not respond.
“Their suffering is enormous and the truth is that there is no improvement for more than a few days or weeks and later they return to their hell. Appreciating that they would be better off dead for themselves and their families is not always a cognitive distortion but an objective evaluation of their reality.”
However, as another reader pointed out, an issue with the argument presented here is that it presupposes that MAID requires “clinical justification.” But in Canada, “MAID ... is understood as an expression of personal autonomy. Rooted in liberal political philosophy of individualism ... approval for death need not be based on a clinical assessment.” Instead, “death is seen as a ‘right’ that the state must therefore provide.”
Another form of eugenics?
Dr. Miller raised the ethical implications of racial and socioeconomic factors playing a role in the consideration of MAID for those with psychiatric illness.
“Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death?” she asks. “Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out?”
Several readers agreed. “Looking at the disproportionate burden of illness, rates of imprisonment, and application of the death penalty indicates to me that race and socioeconomic status will be an immediate factor in how, where, and with whom MAID for mental illness would be practice in much, if not all, of the U.S.,” wrote one physician.
A Canadian reader expressed similar concerns. “I’ve seen a handful of people, including someone I considered a good friend, opt for MAID because it was easier than living as a disabled person in poverty without adequate mental health care.”
Another Canadian clinician noted that offering people good care can make all the difference. “As a Canadian mental health clinician who served youth with severe mental illness for over 20 years through our socialized medical network, I can attest to the difference good care usually makes in shifting clients from despair and a commitment to death to embracing life once again. Let’s not, as clinicians, embrace easing a government/state-sanctioned pathway to death.”
Some readers believe that these types of issues can’t be solved with a blanket approach, noting that each case is different. “Real life is always more complicated than academic discussions. Having served on a hospital ethics committee, I know that each case is unique,” one reader noted.
Another reader added, “I think all we can do as physicians is to let people decide for themselves and participate only if our conscience allows.”
A version of this article first appeared on Medscape.com.
Until recently, this contentious issue applied only to patients with physical illnesses who want to end their suffering and who seek out a physician willing to assist with that objective. In the United States and other countries, this is the patient population who may be able to avail themselves of this option.
However, newly proposed legislation in Canada – which has the largest number of physician-assisted deaths worldwide – would expand the indication for MAID to include serious mental illness. Originally set to be passed in March 2023, the law has been deferred for final decision until March 2024.
A recent commentary by psychiatrist Dinah Miller, MD, explored the ethics of this proposed legislation for mental health professionals. “To offer the option of death facilitated by the very person who is trying to get [patients with serious mental illness] better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide,” Dr. Miller wrote. “As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it?”
Dr. Miller’s piece garnered a huge amount of reader response that included many laudatory comments: a “nuanced and open-ended inquiry here,” “timely and honest,” and “beautifully written.” One reader thanked the author for “this thoughtful, questioning, and open reflection on what it means to be a psychiatrist facing a thorny and deeply personal practice and philosophical question.”
Cognitive distortion or objective reality?
Many readers were opposed to any type of physician involvement in hastening a patient’s death, regardless of whether the condition is medical or psychiatric. “Let others who wish to die make their own arrangement without the aid of the medical profession,” one reader wrote.
But others felt that for those with terminal physical illnesses or intractable pain, it is justified for medical professionals to either facilitate death or, at the very least, withhold life-prolonging treatments.
A critical-care physician described responding to families’ accusations that withdrawal of life-sustaining measures means “playing God.” On the contrary, the physician wrote, “there is a limit to our abilities; and withdrawing those life-prolonging interventions allows nature or God or whatever to play a role and take its course.”
Another U.S. reader pointed out that “multiple polls in this country have shown that the majority of the general public, physicians in general and psychiatrists in particular, support the option of MAID for the terminally ill. They do not find it at variance with their calling as physicians.”
“I and many of my elderly friends don’t fear death but fear prolonged dementia with its dependency and lack of quality of life,” one reader wrote. “We would be much more at peace if we could put in our advanced directive that we request MAID once some point of dependency has been reached.”
Another wrote that in the event of entering a state of “degrading dependency and hardship on the family, please let me go peacefully, without burdening others, into that good night [of death].”
Many felt that not only physical illness but also the prospect of cognitive degeneration – specifically dementia – also justifies assisting patient death.
“Enormous suffering”
One Canadian reader noted that provisions for advance consent are now in place in Canada for those facing the prospect of neurodegenerative disease and who are still mentally competent to make such decisions.
But therein lies the rub – the concept of an advanced directive goes to the question of decisional capacity. Dr. Miller noted that “depression distorts cognition and leads many patients to believe that they would be better off dead and that their loves ones would be better off without them.”
The concept of “cognitive distortion” implies that the illness itself may impede the decisional capacity required for an advanced directive or a decision made in the moment, in the absence of such a directive. Dr. Miller asked, “How do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?”
One reader attested to this from personal experience. “As both a physician and a sufferer of severe, often profound depression for 50 years, I can confidently say that ... the pursuit of death is the result of an impaired mental state, which simultaneously prevents a rational decision.”
Another agreed. “As a psychiatrist, I treated suicidal patients almost every day of my 27-year career. I believe in making every effort to prevent the suicide of a healthy depressed person and I do not support MAID for psychiatric conditions. But I do support MAID for the terminally ill.”
Other readers disagreed. In the words of one commentator, “I think that if we are going to help mentally ill people, we have to consider their choices. The stress imposed by a severe/intractable mental illness is as bad as any other devastating medical illness. If no one is going to hold their hand in life (as support services are limited and psychiatric treatments often fail), allow a medical professional to hold their hand through their final moments.”
A psychiatrist described very ill patients with treatment-resistant bipolar disorder who had not only received medications, including ketamine, but had also received electroconvulsive therapy and still did not respond.
“Their suffering is enormous and the truth is that there is no improvement for more than a few days or weeks and later they return to their hell. Appreciating that they would be better off dead for themselves and their families is not always a cognitive distortion but an objective evaluation of their reality.”
However, as another reader pointed out, an issue with the argument presented here is that it presupposes that MAID requires “clinical justification.” But in Canada, “MAID ... is understood as an expression of personal autonomy. Rooted in liberal political philosophy of individualism ... approval for death need not be based on a clinical assessment.” Instead, “death is seen as a ‘right’ that the state must therefore provide.”
Another form of eugenics?
Dr. Miller raised the ethical implications of racial and socioeconomic factors playing a role in the consideration of MAID for those with psychiatric illness.
“Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death?” she asks. “Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out?”
Several readers agreed. “Looking at the disproportionate burden of illness, rates of imprisonment, and application of the death penalty indicates to me that race and socioeconomic status will be an immediate factor in how, where, and with whom MAID for mental illness would be practice in much, if not all, of the U.S.,” wrote one physician.
A Canadian reader expressed similar concerns. “I’ve seen a handful of people, including someone I considered a good friend, opt for MAID because it was easier than living as a disabled person in poverty without adequate mental health care.”
Another Canadian clinician noted that offering people good care can make all the difference. “As a Canadian mental health clinician who served youth with severe mental illness for over 20 years through our socialized medical network, I can attest to the difference good care usually makes in shifting clients from despair and a commitment to death to embracing life once again. Let’s not, as clinicians, embrace easing a government/state-sanctioned pathway to death.”
Some readers believe that these types of issues can’t be solved with a blanket approach, noting that each case is different. “Real life is always more complicated than academic discussions. Having served on a hospital ethics committee, I know that each case is unique,” one reader noted.
Another reader added, “I think all we can do as physicians is to let people decide for themselves and participate only if our conscience allows.”
A version of this article first appeared on Medscape.com.
Until recently, this contentious issue applied only to patients with physical illnesses who want to end their suffering and who seek out a physician willing to assist with that objective. In the United States and other countries, this is the patient population who may be able to avail themselves of this option.
However, newly proposed legislation in Canada – which has the largest number of physician-assisted deaths worldwide – would expand the indication for MAID to include serious mental illness. Originally set to be passed in March 2023, the law has been deferred for final decision until March 2024.
A recent commentary by psychiatrist Dinah Miller, MD, explored the ethics of this proposed legislation for mental health professionals. “To offer the option of death facilitated by the very person who is trying to get [patients with serious mental illness] better seems so counter to everything I have learned and contradicts our role as psychiatrists who work so hard to prevent suicide,” Dr. Miller wrote. “As psychiatrists, do we offer hope to our most vulnerable patients, or do we offer death? Do we rail against suicide, or do we facilitate it?”
Dr. Miller’s piece garnered a huge amount of reader response that included many laudatory comments: a “nuanced and open-ended inquiry here,” “timely and honest,” and “beautifully written.” One reader thanked the author for “this thoughtful, questioning, and open reflection on what it means to be a psychiatrist facing a thorny and deeply personal practice and philosophical question.”
Cognitive distortion or objective reality?
Many readers were opposed to any type of physician involvement in hastening a patient’s death, regardless of whether the condition is medical or psychiatric. “Let others who wish to die make their own arrangement without the aid of the medical profession,” one reader wrote.
But others felt that for those with terminal physical illnesses or intractable pain, it is justified for medical professionals to either facilitate death or, at the very least, withhold life-prolonging treatments.
A critical-care physician described responding to families’ accusations that withdrawal of life-sustaining measures means “playing God.” On the contrary, the physician wrote, “there is a limit to our abilities; and withdrawing those life-prolonging interventions allows nature or God or whatever to play a role and take its course.”
Another U.S. reader pointed out that “multiple polls in this country have shown that the majority of the general public, physicians in general and psychiatrists in particular, support the option of MAID for the terminally ill. They do not find it at variance with their calling as physicians.”
“I and many of my elderly friends don’t fear death but fear prolonged dementia with its dependency and lack of quality of life,” one reader wrote. “We would be much more at peace if we could put in our advanced directive that we request MAID once some point of dependency has been reached.”
Another wrote that in the event of entering a state of “degrading dependency and hardship on the family, please let me go peacefully, without burdening others, into that good night [of death].”
Many felt that not only physical illness but also the prospect of cognitive degeneration – specifically dementia – also justifies assisting patient death.
“Enormous suffering”
One Canadian reader noted that provisions for advance consent are now in place in Canada for those facing the prospect of neurodegenerative disease and who are still mentally competent to make such decisions.
But therein lies the rub – the concept of an advanced directive goes to the question of decisional capacity. Dr. Miller noted that “depression distorts cognition and leads many patients to believe that they would be better off dead and that their loves ones would be better off without them.”
The concept of “cognitive distortion” implies that the illness itself may impede the decisional capacity required for an advanced directive or a decision made in the moment, in the absence of such a directive. Dr. Miller asked, “How do we determine whether patients with serious mental illness are competent to make such a decision or whether it is mental illness that is driving their perception of a future without hope?”
One reader attested to this from personal experience. “As both a physician and a sufferer of severe, often profound depression for 50 years, I can confidently say that ... the pursuit of death is the result of an impaired mental state, which simultaneously prevents a rational decision.”
Another agreed. “As a psychiatrist, I treated suicidal patients almost every day of my 27-year career. I believe in making every effort to prevent the suicide of a healthy depressed person and I do not support MAID for psychiatric conditions. But I do support MAID for the terminally ill.”
Other readers disagreed. In the words of one commentator, “I think that if we are going to help mentally ill people, we have to consider their choices. The stress imposed by a severe/intractable mental illness is as bad as any other devastating medical illness. If no one is going to hold their hand in life (as support services are limited and psychiatric treatments often fail), allow a medical professional to hold their hand through their final moments.”
A psychiatrist described very ill patients with treatment-resistant bipolar disorder who had not only received medications, including ketamine, but had also received electroconvulsive therapy and still did not respond.
“Their suffering is enormous and the truth is that there is no improvement for more than a few days or weeks and later they return to their hell. Appreciating that they would be better off dead for themselves and their families is not always a cognitive distortion but an objective evaluation of their reality.”
However, as another reader pointed out, an issue with the argument presented here is that it presupposes that MAID requires “clinical justification.” But in Canada, “MAID ... is understood as an expression of personal autonomy. Rooted in liberal political philosophy of individualism ... approval for death need not be based on a clinical assessment.” Instead, “death is seen as a ‘right’ that the state must therefore provide.”
Another form of eugenics?
Dr. Miller raised the ethical implications of racial and socioeconomic factors playing a role in the consideration of MAID for those with psychiatric illness.
“Might those who are poor, who have less access to expensive treatment options and social support, be more likely to request facilitated death?” she asks. “Do we risk facilitating a patient’s demise when other options are unavailable because of a lack of access to treatment or when social and financial struggles exacerbate a person’s hopelessness? Should we worry that psychiatric euthanasia will turn into a form of eugenics where those who can’t contribute are made to feel that they should bow out?”
Several readers agreed. “Looking at the disproportionate burden of illness, rates of imprisonment, and application of the death penalty indicates to me that race and socioeconomic status will be an immediate factor in how, where, and with whom MAID for mental illness would be practice in much, if not all, of the U.S.,” wrote one physician.
A Canadian reader expressed similar concerns. “I’ve seen a handful of people, including someone I considered a good friend, opt for MAID because it was easier than living as a disabled person in poverty without adequate mental health care.”
Another Canadian clinician noted that offering people good care can make all the difference. “As a Canadian mental health clinician who served youth with severe mental illness for over 20 years through our socialized medical network, I can attest to the difference good care usually makes in shifting clients from despair and a commitment to death to embracing life once again. Let’s not, as clinicians, embrace easing a government/state-sanctioned pathway to death.”
Some readers believe that these types of issues can’t be solved with a blanket approach, noting that each case is different. “Real life is always more complicated than academic discussions. Having served on a hospital ethics committee, I know that each case is unique,” one reader noted.
Another reader added, “I think all we can do as physicians is to let people decide for themselves and participate only if our conscience allows.”
A version of this article first appeared on Medscape.com.
TBI tied to increased mental health diagnoses, time to suicide
Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.
“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.
“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”
The findings were published online in JAMA Network Open.
Largest, longest study to date
Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.
Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.
Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.
New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.
There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).
But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
Sharp differences in time to suicide
Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.
Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.
The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.
“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
Applicable to civilians?
“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.
The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.
“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”
However, the authors caution against applying these findings in military veterans to civilians.
“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.
The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
A version of this article first appeared on Medscape.com.
Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.
“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.
“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”
The findings were published online in JAMA Network Open.
Largest, longest study to date
Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.
Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.
Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.
New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.
There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).
But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
Sharp differences in time to suicide
Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.
Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.
The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.
“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
Applicable to civilians?
“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.
The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.
“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”
However, the authors caution against applying these findings in military veterans to civilians.
“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.
The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
A version of this article first appeared on Medscape.com.
Investigators also found that increases in new mental health diagnoses are significantly higher in soldiers with a history of TBI – in some cases, strikingly higher. For example, cases of substance use disorder rose by 100% among veterans with TBI compared to just 14.5% in those with no brain injury.
“We had had pieces of these findings for a long time but to be able to lay out this longitudinal story over time is the part that’s new and important to really switch the focus to people’s whole lives and things that happen over time, both psychological and physical,” lead author Lisa Brenner, PhD, director of the Veterans Health Administration (VHA) Rocky Mountain Mental Illness Research Education and Clinical Center, Aurora, Colo., said in an interview.
“If we take that life-course view, it’s a very different way about thinking about conceptualizing exposures and conceptualizing risk and it’s a different way of thinking about treatment and prevention,” added Dr. Brenner, professor of physical medicine and rehabilitation, psychiatry, and neurology at the University of Colorado, Aurora. “I think that definitely applies to civilian populations.”
The findings were published online in JAMA Network Open.
Largest, longest study to date
Researchers have long suspected that TBI and a higher rate of new mental illness and a shorter time to suicide are all somehow linked. But this study examined all three components longitudinally, in what is thought to be the largest and longest study on the topic to date, including more than 860,000 people who were followed for up to a decade.
Investigators studied health data from the Substance Use and Psychological Injury Combat Study database on 860,892 U.S. Army soldiers who returned from deployment in Iraq or Afghanistan between 2008 and 2014 and were 18-24 years old at the end of that deployment. They then examined new mental health diagnoses and suicide trends over time.
Nearly 109,000 (12.6%) experienced a TBI during deployment, and 2,695 had died by suicide through the end of 2018.
New-onset diagnoses of anxiety, mood disorders, posttraumatic stress disorder, alcohol use, and substance use disorder (SUD) after deployment were all more common in soldiers who experienced PTSD while serving compared with those with no history of TBI.
There was a 67.7% increase in mood disorders in participants with TBI compared with a 37.5% increase in those without TBI. The increase in new cases of alcohol use disorder was also greater in the TBI group (a 31.9% increase vs. a 10.3% increase).
But the sharpest difference was the increase in substance use disorder among those with TBI, which rose 100% compared with a 14.5% increase in solders with no history of TBI.
Sharp differences in time to suicide
Death by suicide was only slightly more common in those with TBI compared with those without (0.4% vs. 0.3%, respectively). But those with a brain injury committed suicide 21.3% sooner than did those without a head injury, after the researchers controlled for sex, age, race, ethnicity, and fiscal year of return from deployment.
Time to suicide was faster in those with a TBI and two or more new mental health diagnoses and fastest among those with TBI and a new SUD diagnosis, who took their own lives 62.8% faster than did those without a TBI.
The findings offer an important message to medical professionals in many different specialties, Dr. Brenner said.
“Folks in mental health probably have a lot of patients who have brain injury in their practice, and they don’t know it and that’s an important thing to know,” she said, adding that “neurologists should screen for depression and other mental health conditions and make sure those people have evidence-based treatments for those mental health conditions while they’re addressing the TBI-related symptoms.”
Applicable to civilians?
“The complex interplay between TBI, its potential effects on mental health, and risk of suicide remains a vexing focus of ongoing investigations and academic inquiry,” Ross Zafonte, DO, president of Spaulding Rehabilitation Hospital Network and professor and chair of physical medicine and rehabilitation at Harvard Medical School, Boston, and colleagues, wrote in an accompanying editorial.
The study builds on earlier work, they added, and praised the study’s longitudinal design and large cohort as key to the findings. The data on increased rates of new-onset substance use disorder, which was also associated with a faster time to suicide in the TBI group, were of particular interest.
“In this work, Brenner and colleagues identified substance use disorder as a key factor in faster time to suicide for active-duty service members with a history of TBI compared with those without TBI and theorized that a multiple stress or exposure burden may enhance risk,” they wrote. “This theory is reasonable and has been postulated among individuals with medical sequelae linked to TBI.”
However, the authors caution against applying these findings in military veterans to civilians.
“While this work is critical in the military population, caution should be given to avoid direct generalization to other populations, such as athletes, for whom the linkage to suicidal ideation is less understood,” they wrote.
The study was funded by National Institute of Mental Health and Office of the Director at National Institutes of Health. Dr. Brenner has received personal fees from Wolters Kluwer, Rand, American Psychological Association, and Oxford University Press and serves as a consultant to sports leagues via her university affiliation. Dr. Zafonte reported receiving royalties from Springer/Demos; serving as a member of the editorial boards of Journal of Neurotrauma and Frontiers in Neurology and scientific advisory boards of Myomo, Nanodiagnostics, Onecare.ai, and Kisbee; and evaluating patients in the MGH Brain and Body-TRUST Program, which is funded by the National Football League Players Association.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Experts highlight benefits and offer caveats for first postpartum depression pill
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For the first time, the Food and Drug Administration approved a pill taken once daily for 14 days to help women manage the often strong, sometimes overpowering symptoms of postpartum depression.
for a condition that affects an estimated 1 in 8 women in the United States. What will it mean for easing symptoms such as hopelessness, crankiness, and lack of interest in bonding with the baby or, in the case of multiples, babies – and in some cases, thoughts of death or suicide?
A fast-acting option
“We don’t have many oral medications that are fast-acting antidepressants, so this is incredibly exciting,” said Sarah Oreck, MD, a psychiatrist in private practice in Los Angeles who specializes in reproductive psychiatry. The rapid response is likely because the medication targets the hormonal mechanism underlying postpartum depression, she added.
Zuranolone (Zurzuvae, Biogen/Sage) is different from most other antidepressants – it is designed to be taken for a shorter period. Also, Because zuranolone is a pill, it is more convenient to take than the other FDA-approved treatment, the IV infusion brexanolone (Zulresso, Sage).
“It’s obviously game changing to have something in pill form. The infusion has to be done at an infusion center to monitor people for any complications,” said Kimberly Yonkers, MD, a psychiatrist specializing in women’s health, a Distinguished Life Fellow of the American Psychiatric Association (APA), and the Katz Family Chair of Psychiatry at the University of Massachusetts Chan Medical School/UMass Memorial Medical Center in Worcester.
Women may experience improvement in postpartum depression in as soon as 3 days after starting the medication. In contrast, “typical antidepressants can take up to 2 weeks before patients notice a difference and 4 to 8 weeks to see a full response. A fast-acting pill that can be taken orally could be an ideal option for the 15% to 20% of women who experience postpartum depression,” said Priya Gopalan, MD, a psychiatrist with UPMC Western Psychiatric Hospital and Magee-Womens Hospital in Pittsburgh.
The medical community, and reproductive psychiatrists in particular, has always suspected differences in the biological underpinnings of postpartum depression and major depressive disorder, Dr. Oreck said. “We know that postpartum depression looks different from major depressive disorder and that hormonal shifts during pregnancy and postpartum are a huge risk factor for postpartum depression,” she said.
Although selective serotonin reuptake inhibitors (SSRIs) are helpful and currently the standard of care for treating moderate to severe postpartum depression in combination with therapy, Dr. Oreck added, early studies suggest that zuranolone may work faster and potentially be more effective than SSRIs in treating the condition.
Zuranolone is a version of a naturally occurring hormone called allopregnanolone, a metabolite of progesterone. Concentrations of allopregnanolone rise dramatically during pregnancy and then drop precipitously after childbirth. Zuranolone works through modulating GABA-A, a neurotransmitter implicated in the development of depression.
“It is encouraging that postpartum individuals may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, MD, interim CEO and chief of clinical practice and health equity and quality for the American College of Obstetricians and Gynecologists (ACOG).
ACOG recommends women be screened for depression at least three times – during early pregnancy, later in pregnancy, and again after delivery. A decision to start this or any other medicine should be individualized and based on shared decision-making between a patient and doctor, Dr. Zahn added.
The cost of zuranolone is not yet known. Dr. Yonkers said cost of the infusion can serve as a cautionary tale for the manufacturer. Some reports put the infusion cost at $34,000. “Cost is going to be an important component to this. The previous intervention was priced so high that it was not affordable to many people and it was difficult to access.”
Beyond ‘baby blues’
The APA has changed the name from “postpartum depression” to “peripartum depression” because evidence suggests feelings and symptoms also can start late in pregnancy. “It means you don’t have to wait until somebody delivers to screen for depression. We have to recognize that depression can occur during pregnancy,” Dr. Yonkers said. “In fact it is not uncommon during the third trimester.”
No matter when it starts, the condition can be “very serious,” particularly if the person already experiences depression, including bipolar disorder, Dr. Yonkers added.
Postpartum depression “is more than just ‘baby blues.’ It is a potentially debilitating illness that causes feelings of intense sadness and worthlessness, making it difficult to care for and bond with your newborn,” Dr. Gopalan said.
Can be a medical emergency
Severe postpartum depression requires immediate attention and treatment.
“One of the things we have to be cautious about is for people with previous predisposition to hurt themselves,” Dr. Yonkers said. “It is therefore important to consider somebody’s medical and behavioral health history as well.
“For an individual with recurring depression or severe episodes of depression, this may not be sufficient, because they are just going to get these 14 days of therapy,” Dr. Yonkers said. “They may need ongoing antidepressants.
“It may not be the right pill for everybody,” Dr. Yonkers added. She recommended everyone be followed closely during and after treatment “to make sure they are responding and to monitor for relapse.”
The science that led to approval
The clinical trials showed early response in patients with severe postpartum depression. Researchers conducted two studies of women who developed a major depressive episode in the third trimester of pregnancy or within 4 weeks of delivery. They found women who took zuranolone once in the evening for 14 days “showed significantly more improvement in their symptoms compared to those in the placebo group.”
The antidepressant effect lasted at least 4 weeks after stopping the medication.
Drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection were the most common side effects. The label has a boxed warning noting that the medication can affect a person’s ability to drive and perform other potentially hazardous activities. Use of zuranolone may also cause suicidal thoughts and behavior, according to an FDA news release announcing the approval.
The start of more help for mothers?
Zuranolone is not a cure-all. As with most psychiatric prescriptions, the medication likely will work best in conjunction with behavioral health treatments such as psychotherapy, use of other medications, behavioral management, support groups, and self-care tools such as meditation, exercise, and yoga, Dr. Gopalan said.
Dr. Oreck said she hopes this first pill approval will lead to more discoveries. “I hope this is the beginning of more innovation and development of novel treatments that can target women’s mental health issues specifically – female reproductive hormones impact mental health in unique ways and it’s exciting to finally see research and development dollars dedicated to them,” she said. “The FDA approval of this pill provides the potential to improve the lives of millions of Americans suffering from postpartum depression.”
Dr. Oreck, Dr. Yonkers, Dr. Gopalan, and Dr. Zahn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.