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Mental Health Interventions for Refugee Children
In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.1
Risk Factors and Protective Factors
To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.4 It will be summarized in this section with some relevant personal reflection.
In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.
In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
Mental Health Interventions
In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.5 She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.
On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.
On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.
School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
Summary
In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.
Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*
References
1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.
2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.
3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY
4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.
5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.
*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.
In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.1
Risk Factors and Protective Factors
To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.4 It will be summarized in this section with some relevant personal reflection.
In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.
In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
Mental Health Interventions
In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.5 She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.
On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.
On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.
School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
Summary
In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.
Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*
References
1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.
2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.
3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY
4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.
5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.
*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.
In my previous article, “Mental Health Characteristics of Refugee Children,” we learned that in recent decades, refugeeism has become a growing problem that disproportionately affects children. Refugee children and their families experience a variety of traumas, often sustained across years and even decades, because of armed conflict, persecution, social upheavals, or environmental disasters. Refugees are at greater risks for PTSD and affective and psychotic disorders presumably due to increased traumatic life events before, during, and after migration. I used my own experience as a child refugee from Vietnam to elucidate the stressors evident in various phases of forced displacement.1
Risk Factors and Protective Factors
To a certain extent, the experiences of refugees are universal. All refugees experience some sort of humanitarian crisis that forces an emergent escape from their home across international borders to a new resettlement area. It is important to note that internally displaced people do not meet the United Nations’ (UN) official designation of refugee status; however, some agencies use a broader definition where they are designated as such.2,3 We will refer to those not meeting the UN criteria as displaced people, while refugees are those that do meet the UN criteria. Dr. Mina Fazel’s 2012 systematic review in The Lancet of mental health risk factors and protective factors for displaced and refugee children is the most comprehensive of its kind.4 It will be summarized in this section with some relevant personal reflection.
In terms of risk factors, external displacement likely results in additional stress and trauma, presumably from the lack of assess to one’s culture and the host country’s language. Understandably, this makes rebuilding of one’s life more difficult. Several studies show that displaced/refugee children experience more difficulty with psychosocial adaptation than non-displaced children. Violence, directly experienced or indirectly feared, both to the child and their parents, was the strongest predictor of mental health problems and withdrawn behavior. Children who were separated from their parents clearly fared worst in their mental health than those who did not, which is not surprising given the nature of their dependence on caregivers for protection and guidance. During resettlement, experienced or perceived discrimination from the host country was also a risk factor, as well as instability in housing and a drawn-out resettlement process. Female sex was a risk factor mainly for emotional problems. Poor financial support post-migration is associated with depression, but it is unclear whether pre-migration financial status was protective. From my own experience, it is likely not, given that once one becomes a refugee one does not have access to one’s wealth, except that which could be hidden on one’s body. Another risk factor was also if one’s parent had psychiatric problems or was single. Due to the migration, my mother was separated permanently from her husband, which caused her extraordinary isolation and loneliness, something that was palpably felt by myself as I grew up.
In terms of protective factors, family cohesion and cultural continuity appear critical. For myself, not only would I not have survived without my mother and aunt, but they constantly protected me from the harsh realities. My mother would distract me with seemingly trivial goals once we got to America, like finally tasting a hamburger, or talking about school and being reunited with my uncle. This is in line with another finding — that children have better mental health outcomes when their parents do not talk about their hardships. Once my family was resettled with my uncle and his family, they played a critical role in smoothing our transition, not only by providing us with housing, but also cultural knowledge. Cultural havens can restore some of the social position and way of life that refugees lose when they are able to reconnect with a society that recognizes their previous achievements and status. Finally, religion also seemed to be a protective factor.
Mental Health Interventions
In 2018, Dr. Fazel identified mental health interventions for refugee children in a narrative review.5 She acknowledged that these conclusions are limited by the paucity of preventive mental health research in children in general, as well as the mobile nature and complex cultural differences of refugee children. This is exacerbated by the small evidence base. Given that, she makes these recommendations for varying levels of interventions: individual, group, family, living circumstances, social interactions, and school.
On an individual level, effective interventions developed to address PTSD include narrative exposure therapy, trauma-focused cognitive behavior therapy, and eye-movement and desensitization therapy. Group-based interventions for trauma, for example school-based PTSD intervention programs in conflicted areas, have either been shown to not be effective, or only effective for reducing depression. The mental health of unaccompanied children separated from family fare better when placed in foster care, rather than other types of social support. This is further enhanced if the foster family is the same ethnicity.
On a family level, improvements in parenting style and parental mental health, family engagement with local culture and structures, and family-based mental health interventions all positively impact refugee children. Not surprisingly, refugee parents have a greater prevalence of mental health conditions. Several studies on refugeeism point out a greater occurrence of intimate partner violence (that negatively affects children) as well has harsher discipline and maltreatment of refugee children. Thus, mental health treatment for parents also directly improves the well-being of their children. Teaching parenting skills to mitigate the violent effect of their PTSD symptoms, as well as parenting classes that teach gentler styles, have been shown to reduce harsh parenting and mitigate aggressive behaviors in these children. These improvements are enhanced when these classes are taught by other refugees themselves.
School is key for helping refugee children since it is a site where they can access language proficiency, successful acculturation, and medical and mental health services. Several studies have identified the positive effects of better parental engagement with school, resulting in improved academic performance and reduced levels of depressive and PTSD symptoms. A review of learning problems in refugee children identified several factors for success. These include high academic and life ambition, parental involvement in education, accurate educational assessment and grade placement, teacher understanding of linguistic and cultural heritage, culturally appropriate school transition, supportive peer relationships, and successful acculturation. School certainly was key for my acculturation and language proficiency. When I arrived at 6 years old I was selectively mute for my year in first grade, namely because I did not know how to speak English and because I did not share the culture. However, my teacher correctly identified my deficiency and chose to place me in kindergarten, which allowed me the time to gain English proficiency. Though I was always the oldest one in class, that remediation was key in allowing eventual success in school leading up to my admission to UC Berkeley.
Summary
In recent decades, refugeeism has become a growing problem that disproportionately affects children leading to traumas sustained across years and even decades, and greater risks for PTSD, as well as affective and psychotic disorders. Risk factors include the experience of violence, the separation from family, female gender, discrimination in the host country, unstable housing, and a drawn-out resettlement process. Protective factors consist of family cohesion, cultural continuity, support at schools, being protected from the truth of their harsh reality, stable housing, language acquisition, and quick resettlement. From these factors, effective mental interventions have been found to be the promotion of these protective factors as well as support for parental mental health and parenting skills, better parental engagement at school, and schools that correctly identify and address these children’s educational needs.
Dr. Nguyen is a second-year resident at UCSF Fresno Psychiatry Residency. He was a public high school English teacher for 15 years previously.*
References
1. Nguyen D. Mental Health Characteristics of Refugee Children. Pediatric News. 2023 Nov. 14. https://www.mdedge.com/pediatrics/article/266518/mental-health/mental-health-characteristics-refugee-children.
2. Office of the United Nations High Commissioner for Refugees. The Refugee Concept Under International Law. Global Compact for Safe, Orderly and Regular Migration. 2018 March 8. https://www.unhcr.org/sites/default/files/legacy-pdf/5aa290937.pdf.
3. Winer JP. Mental Health Practice with Immigrant and Refugee Youth [Power Point Slides]. Michigan Medicine. 2021 June 24. https://www.youtube.com/watch?v=ICkg4132SQY
4. Fazel M et al. Mental Health of Displaced and Refugee Children Resettled in High-Income Countries: Risk and Protective Factors. Lancet. 2012 Jan 21;379(9812):266-282. doi: 10.1016/S0140-6736(11)60051-2.
5. Fazel M, Betancourt TS. Preventive Mental Health Interventions for Refugee Children and Adolescents in High-Income Settings. Lancet Child Adolesc Health. 2018 Feb;2(2):121-132. doi: 10.1016/S2352-4642(17)30147-5.
*Correction, 2/27: An earlier version of this article misstated Dr. Nguyen's affiliation.
Parent-Led Digital CBT Effective for Childhood Anxiety
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
while substantially reducing cost and therapist time, new research showed.
In a randomized controlled trial, children participating in the program Online Support and Intervention (OSI) for Child Anxiety showed similar reductions in anxiety and improvements in daily functioning as peers receiving standard CBT.
“This study shows that by making the most of digital tools, we can deliver effective treatments more efficiently, helping services to better meet the growing demand for mental health services for children in ways that can also be more accessible for many families,” lead investigator Cathy Creswell, PhD, Departments of Experimental Psychology and Psychiatry, Oxford University, Oxford, England, told this news organization.
“I believe by incorporating this approach into standard care, we could address some of the major challenges faced by services and families,” Dr. Creswell added. “We are now moving the work out of the research environment into routine practice.”
The study was published online in The Lancet Psychiatry
Care Gaps for Common Problem
Anxiety is common in children, yet gaps exist between needed and available care, which investigators say could be filled by digitally augmented psychological treatments.
OSI, the digital platform used in the current study, was designed with therapists and families to aid parents in helping their children overcome problems with anxiety with remote therapist support.
The program provides parents with the core CBT content in accessible forms, including information in text, audio, and video and exercises supported by worksheets and quizzes.
There is also an optional child game app to help motivate the child to engage with the intervention. Parents are supported with weekly brief telephone or video call sessions with the therapist.
The two-arm randomized controlled non-inferiority trial included 444 families from 34 participating Child and Adolescent Mental Health Services (CAMHS) sites in England and Northern Ireland. Half received OSI plus therapist support and half CAMHS treatment as usual. The children were between 5 and 12 years old.
A total of 176 (79%) participants in the OSI plus therapist support group and 164 (74%) in the treatment as usual group completed the 26-week assessment.
‘Compelling’ Evidence
The primary clinical outcome was parent-reported interference caused by child anxiety at 26 weeks, using the Child Anxiety Impact Scale-Parent report.
On this measure, OSI plus therapist support was non-inferior to usual treatment, with a standardized mean difference of only 0.01 (95% CI, −0.15 to 0.17; P < .0001).
The intervention was also significantly non-inferior to usual treatment across all secondary outcomes, including total anxiety and depression scores, overall functioning, peer relationship problems, and prosocial behavior.
In addition, OSI plus therapist support was associated with nearly 60% less therapist time (182 min on average vs 307 min) and with lower costs than standard treatment. The OSI program was “likely to be cost-effective under several scenarios,” the researchers reported. Qualitative interviews showed “good” acceptability of the online program.
“This trial presents compelling clinical evidence and promising cost-effectiveness evidence that digitally augmented psychological therapies with therapist support can increase efficiencies in and access to child mental health services without compromising patient outcomes,” Dr. Creswell and colleagues concluded.
“Efforts are now needed to take full advantage of the opportunity that digitally augmented psychological treatments can bring to drive a step change in children’s mental health services, learning from successful examples of digital implementation elsewhere in health services,” they added.
‘Call to Action’
“We desperately need more trials” like this one, which showed the “clear value of a digitally augmented intervention over the usual face-to-face treatment” for child anxiety, wrote the authors of an accompanying editorial.
“Moreover, with the intervention delivered across 34 CAMHS settings in England and Northern Ireland, this study gives us confidence that the new intervention is effective in a range of clinical contexts at least in high-income countries and offers invaluable information about barriers and facilitators to future implementation,” wrote Sam Cartwright-Hatton, PhD, with the University of Sussex, Brighton and Hove, and Abby Dunn, PhD, with the University of Surrey, Guilford, England. “The potential benefits to overburdened services are clear.”
“That regular CAMHS clinicians, with minimal training and support from researchers, delivered the intervention within their standard caseload shows that it can be embedded within routine practice without a requirement for highly prepared and supervised clinicians,” they added.
However, more information is needed on the content and quality of the traditional CBT provided in the control group. It’s also important to determine if the program would be as effective with even less clinical support and in all types of childhood anxiety.
In addition, most clinicians in the OSI group only treated one patient with the new program and didn’t take advantage of the additional support offered by the research team, “which means we have not seen the true effectiveness of this intervention in the hands of well-practiced and well-trained staff,” Drs. Cartwright-Hatton and Dunn wrote.
Analyses included recruitment at the lower target amount, and one fifth of children were not offered treatment within the 12-week window recommended in the trial, they added.
“Although these issues place limits on the conclusions that can be drawn, they should also be seen as a call to action,” they wrote, adding that real-world clinical trials with greater clinician participation are needed. “All credit to this exceptional team for making this trial happen and for making it work as well as it did.”
The study was funded by the Department for Health and Social Care, UK Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, and Oxford Health NIHR Biomedical Research Centre. Dr. Creswell is co-developer of the OSI platform and the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. Dr. Cartwright-Hatton and Dr. Dunn had no disclosures.
A version of this article appeared on Medscape.com.
FROM THE LANCET PSYCHIATRY
Stimulant Medications for ADHD — the Good, the Bad, and the Ugly
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Children with attention-deficit/hyperactivity disorder (ADHD) are mainly cared for in primary care settings by us. Management of this chronic neurodevelopmental condition that affects 5+% of children worldwide should include proper diagnosis, assessment for contributing and comorbid conditions, behavioral intervention (the primary treatment for preschoolers), ensuring good sleep and nutrition, and usually medication.
Because stimulants are very effective for reducing ADHD symptoms, we may readily begin these first-line medications even on the initial visit when the diagnosis is determined. But are we really thoughtful about knowing and explaining the potential short- and long-term side effects of these medications that may then be used for many years? Considerable discussion with the child and parents may be needed to address their concerns, balanced with benefits, and to make a plan for their access and use of stimulants (and other medications for ADHD not the topic here).
Consider the Side Effects
In children older than 6 years, some form of either a methylphenidate (MPH) or a dextroamphetamine (DA) class of stimulant have been shown to be equally effective in reducing symptoms of ADHD in about 77% of cases, but side effects are common, mostly mild, and mostly in the first months of use. These include reduced appetite, abdominal pain, headache, weight loss, tics, jitteriness, and delays in falling asleep. About half of all children treated will have one of these adverse effects over 5 years, with reduced appetite the most common. There is no difference in effectiveness or side effects by presentation type, i.e. hyperactive, inattentive, or combined, but the DA forms are associated with more side effects than MPH (10% vs. 6%). Medicated preschoolers have more and different side effects which, in addition to those above, may include listlessness, social withdrawal, and repetitive movements. Fortunately, we can reassure families that side effects can usually be readily managed by slower ramp up of dose, spacing to ensure appetite for meals, extra snacks, attention to bowel patterns and bedtime routines, or change in medication class.
Rates of tics while on stimulants are low irrespective of whether DA or MPH is used, and are usually transient, but difficult cases may occur, sometimes as part of Tourette’s, although not a contraindication. Additional side effects of concern are anxiety, irritability, sadness, and overfocusing that may require a change in class of stimulant or to a nonstimulant. Keep in mind that these symptoms may represent comorbid conditions to ADHD, warranting counseling intervention rather than being a medication side effect. Both initial assessment for ADHD and monitoring should look for comorbidities whether medication is used or not.
Measuring height, weight, pulse, and blood pressure should be part of ADHD care. How concerned should you and the family be about variations? Growth rate declines are more common in preschool children; in the PATS study height varied by 20.3%, and weight by 55.2%, more in heavier children. Growth can be protected by providing favored food for school, encouraging eating when hungry, and an evening fourth meal. You can reassure families that, even with continual use of stimulant medicines for years and initial deficits of 2 cm and 2.7 kg compared to expected, no significant differences remain in adulthood.
This longitudinal growth data was collected when short-acting stimulants were the usual, rather than the now common long-acting stimulants given 7 days per week, however. Children on transdermal MPH with 12-hour release over 3 years showed a small but significant delay in growth with the mean deficit rates 1.3 kg/year mainly in the first year, and 0.68 cm/year in height in the second year. If we see growth not recovering as it is expected to after the first year of treatment, we can advise shorter-acting forms, and medication “holidays” on weekends or vacations, that reduce but do not end the deficits. When concerned, a nonstimulant can be selected.
Blood pressure and pulse rate are predictably slightly increased on stimulants (about 2-4 mm Hg and about 3-6 bpm) but not clinically significantly. Although ECGs are not routinely recommended, careful consideration and consultation is warranted before starting stimulants for any patient with structural cardiac abnormalities, unexplained syncope, exertional chest pain, or a family history of sudden death in children or young adults. Neither current nor former users of stimulants for ADHD were found to have greater rates of cardiac events than the general population, however.
Misuse and abuse
Misuse and diversion of stimulants is common (e.g. 26% diverted MPH in the past month; 14% of 12th graders divert DA), often undetected, and potentially dangerous. And the problem is not limited to just the kids. Sixteen percent of parents reported diversion of stimulant medication to another household member, mainly to themselves. Stimulant overdose can occur, especially taken parenterally, and presents with dilated pupils, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and/or seizures. Fortunately, overdose of prescribed stimulants is rarely fatal if medically managed, but recent “fake” Adderall (not from pharmacies) has been circulating. These fake drugs may contain lethal amounts of fentanyl or methamphetamine. Point out to families that a peer-provided stimulant not prescribed for them may have underlying medical or psychiatric issues that increase adverse events. Selling stimulants can have serious legal implications, with punishments ranging from fines to incarceration. A record of arrest during adolescence increases the likelihood of high school dropout, lack of 4-year college education, and later employment barriers. Besides these serious outcomes, it is useful to remind patients that if they deviate from your recommended dosing that you, and others, will not prescribe for them in the future the medication that has been supporting their successful functioning.
You can be fooled about being able to tell if your patients are misusing or diverting the stimulants you prescribe. Most (59%) physicians suspect that more than one of their patients with ADHD has diverted or feigned symptoms (66%) to get a prescription. Women were less likely to suspect their patients than are men, though, so be vigilant! Child psychiatrists had the highest suspicion with their greater proportion of patients with ADHD plus conduct or substance use disorder, who account for 83% of misusers/diverters. We can use education about misuse, pill counts, contracts on dosing, or switching to long-acting or nonstimulants to curb this.
Additional concerns
With more ADHD diagnosis and stimulants used for many years should we worry about longer-term issues? There have been reports in rodent models and a few children of chromosomal changes with stimulant exposure, but reviewers do not interpret these as an individual cancer risk. Record review of patients who received stimulants showed lower numbers of cancer than expected. Nor is there evidence of reproductive effects of stimulants, although use during pregnancy is not cleared.
Stimulants carry a boxed warning as having high potential for abuse and psychological or physical dependence, which is unsurprising given their effects on brain reward pathways. However, neither past nor present use of stimulants for ADHD has been associated with greater substance use long term.
To top off these issues, recent shortages of stimulants complicate ADHD management. Most states require electronic prescribing, US rules only allowing one transfer of such e-prescriptions. With many pharmacies refusing to tell families about availability, we must make multiple calls to locate a source. Pharmacists could help us by looking up patient names of abusers on the registry and identifying sites with adequate supplies.
Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].
Long-Acting Injectable Antipsychotics Reduce Schizophrenia Readmission
Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.
“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.
“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.
The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
Fewer Repeat Stays
Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.
A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.
Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).
The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.
There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.
That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.
Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.
“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.
“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”
Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.
“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.
“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.
The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
Fewer Repeat Stays
Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.
A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.
Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).
The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.
There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.
That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.
Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.
“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.
“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”
Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
Investigators reported the findings support the use of LAI antipsychotics over oral medication following a hospital stay for schizophrenia or schizoaffective disorder.
“I suspect the lower readmission rate that has been observed with long-acting injections has more to do with people forgetting to take a pill each and every day than with any inherent superiority of the injectable medication,” lead author Daniel Greer, PharmD, BCPP, clinical assistant professor at Rutgers University Ernest Mario School of Pharmacy, Piscataway, New Jersey, said in a news release.
“Other studies on the use of antipsychotic medication have found that roughly three fourths of patients do not take oral medications exactly as directed, and it’s much easier to get a shot every few months than it is to take a pill every day, even though the shot requires a trip to the doctor,” Dr. Greer added.
The study was published online on January 17, 2024, in the Journal of Clinical Psychopharmacology.
Fewer Repeat Stays
Investigators compared 30-day readmission rates for all 343 patients with schizophrenia or schizoaffective disorder who were discharged from an inpatient psychiatric unit between August 2019 and June 2022.
A total of 240 patients (70%) were discharged on an oral antipsychotic, most commonly risperidone or olanzapine, and 103 (30%) were sent home on an LAI antipsychotic, most commonly aripiprazole lauroxil or haloperidol decanoate.
Within 30 days of discharge, 22 patients (6.4%) were readmitted for a schizophrenic or schizoaffective exacerbation — two in the LAI antipsychotic group and 20 in the oral antipsychotic group (1.9% vs 8.3%; P = .03).
The LAI antipsychotic group had a higher average daily chlorpromazine equivalent antipsychotic dose than the oral group (477.3 mg vs 278.6 mg; P < .001), which investigators said may indicate a difference in illness severity between the patient groups.
There was no significant between-group difference in the use of anticholinergic medications to treat extrapyramidal symptoms (22% in the LAI group and 31% in the oral group) despite the LAI group receiving greater doses.
That suggests “that both formulations may be equally as likely to cause these adverse effects,” the researchers noted.
Thirty-day readmission rates are important both medically and financially, investigators noted. In schizophrenia, access to medications and nonadherence are “significant problems.” LAI antipsychotic medications may alleviate some of these burdens but come with a high up-front cost.
“Medication access through pharmaceutical company free trial replacement programs may be an option for facilities with restricted formularies or limited medication funding to decrease 30-day readmissions,” investigators wrote.
“The cost of the injections is far lower than the cost of hospital treatments,” Dr. Greer added in the news release. “And each additional visit to the hospital increases the odds that there will be more visits in the future. Every time someone experiences psychosis, they lose gray matter, and they suffer damage that never heals. That’s why it’s so vital to minimize psychotic episodes.”
Chief limitations of the study included its single-center, retrospective chart review design and small sample size. Also, complete patient medication history was not obtained.
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
Mood Interventions May Reduce IBD Inflammation
, according to a new study.
“IBD is a distressing condition, and current medication that reduces inflammation is expensive and can have side effects,” said Natasha Seaton, first author and a PhD student at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London.
“Our study showed that interventions that treat mental health reduce levels of inflammation in the body,” she said. “This indicates that mood interventions could be a valuable tool in our approach to help those with IBD.”
The study was published online in eBioMedicine.
Analyzing Mood Interventions
Ms. Seaton and colleagues conducted a systematic review and meta-analysis of randomized controlled trials in adults with IBD that measured inflammatory biomarker levels and tested a mood intervention, including those aimed at reducing depression, anxiety, stress, or distress or improving emotional well-being.
Looking at data from 28 randomized controlled trials with 1789 participants, the research team evaluated whether mood interventions affected IBD inflammation, particularly IBD indicators such as C-reactive protein and fecal calprotectin, and other general inflammatory biomarkers.
The researchers found mood interventions significantly reduced levels of inflammatory biomarkers, compared with controls, corresponding to an 18% reduction in inflammatory biomarkers.
Psychological therapies had the best outcomes related to IBD inflammation, compared with antidepressants or exercise. These therapies included cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.
Individual analyses of IBD-specific inflammatory markers found small but statistically significant reductions in C-reactive protein and fecal calprotectin after a mood intervention. This could mean mood treatments have positive effects on both inflammation and disease-specific biomarkers, the authors wrote.
In addition, interventions that had a larger positive effect on mood had a greater effect in reducing inflammatory biomarkers. This suggests that a better mood could reduce IBD inflammation, they noted.
“We know stress-related feelings can increase inflammation, and the findings suggest that by improving mood, we can reduce this type of inflammation,” said Valeria Mondelli, MD, PhD, clinical professor of psychoneuroimmunology at King’s IoPPN.
“This adds to the growing body of research demonstrating the role of inflammation in mental health and suggests that interventions working to improve mood could also have direct physical effects on levels of inflammation,” she said. “However, more research is needed to understand exact mechanisms in IBD.”
Cost Benefit
Many IBD interventions and medications can be expensive for patients, have significant negative side effects, and have a lower long-term treatment response, the authors noted. Mood interventions, whether psychological therapy or medication, could potentially reduce costs and improve both mood and inflammation.
Previous studies have indicated that psychosocial factors, as well as mood disorders such as anxiety and depression, affect IBD symptom severity and progression, the authors wrote. However, researchers still need to understand the mechanisms behind this connection, including gut-brain dynamics.
Future research should focus on interventions that have been effective at improving mood in patients with IBD, assess inflammation and disease activity at numerous timepoints, and include potential variables related to illness self-management, the authors wrote.
In addition, implementation of mood interventions for IBD management may require better continuity of care and healthcare integration.
“Integrated mental health support, alongside pharmacological treatments, may offer a more holistic approach to IBD care, potentially leading to reduced disease and healthcare costs,” said Rona Moss-Morris, PhD, senior author and professor of psychology at King’s IoPPN.
Medications taken to reduce inflammation can be costly compared with psychological therapies, she said. “Given this, including psychological interventions, such as cost-effective digital interventions, within IBD management might reduce the need for anti-inflammatory medication, resulting in an overall cost benefit.”
The study was funded by the Medical Research Council (MRC) and National Institute for Health and Care Research Maudsley Biomedical Research Centre, which is hosted by South London and Maudsley NHS Foundation Trust in partnership with King’s College London. Ms. Seaton was funded by an MRC Doctoral Training Partnership. No other interests were declared.
A version of this article appeared on Medscape.com.
, according to a new study.
“IBD is a distressing condition, and current medication that reduces inflammation is expensive and can have side effects,” said Natasha Seaton, first author and a PhD student at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London.
“Our study showed that interventions that treat mental health reduce levels of inflammation in the body,” she said. “This indicates that mood interventions could be a valuable tool in our approach to help those with IBD.”
The study was published online in eBioMedicine.
Analyzing Mood Interventions
Ms. Seaton and colleagues conducted a systematic review and meta-analysis of randomized controlled trials in adults with IBD that measured inflammatory biomarker levels and tested a mood intervention, including those aimed at reducing depression, anxiety, stress, or distress or improving emotional well-being.
Looking at data from 28 randomized controlled trials with 1789 participants, the research team evaluated whether mood interventions affected IBD inflammation, particularly IBD indicators such as C-reactive protein and fecal calprotectin, and other general inflammatory biomarkers.
The researchers found mood interventions significantly reduced levels of inflammatory biomarkers, compared with controls, corresponding to an 18% reduction in inflammatory biomarkers.
Psychological therapies had the best outcomes related to IBD inflammation, compared with antidepressants or exercise. These therapies included cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.
Individual analyses of IBD-specific inflammatory markers found small but statistically significant reductions in C-reactive protein and fecal calprotectin after a mood intervention. This could mean mood treatments have positive effects on both inflammation and disease-specific biomarkers, the authors wrote.
In addition, interventions that had a larger positive effect on mood had a greater effect in reducing inflammatory biomarkers. This suggests that a better mood could reduce IBD inflammation, they noted.
“We know stress-related feelings can increase inflammation, and the findings suggest that by improving mood, we can reduce this type of inflammation,” said Valeria Mondelli, MD, PhD, clinical professor of psychoneuroimmunology at King’s IoPPN.
“This adds to the growing body of research demonstrating the role of inflammation in mental health and suggests that interventions working to improve mood could also have direct physical effects on levels of inflammation,” she said. “However, more research is needed to understand exact mechanisms in IBD.”
Cost Benefit
Many IBD interventions and medications can be expensive for patients, have significant negative side effects, and have a lower long-term treatment response, the authors noted. Mood interventions, whether psychological therapy or medication, could potentially reduce costs and improve both mood and inflammation.
Previous studies have indicated that psychosocial factors, as well as mood disorders such as anxiety and depression, affect IBD symptom severity and progression, the authors wrote. However, researchers still need to understand the mechanisms behind this connection, including gut-brain dynamics.
Future research should focus on interventions that have been effective at improving mood in patients with IBD, assess inflammation and disease activity at numerous timepoints, and include potential variables related to illness self-management, the authors wrote.
In addition, implementation of mood interventions for IBD management may require better continuity of care and healthcare integration.
“Integrated mental health support, alongside pharmacological treatments, may offer a more holistic approach to IBD care, potentially leading to reduced disease and healthcare costs,” said Rona Moss-Morris, PhD, senior author and professor of psychology at King’s IoPPN.
Medications taken to reduce inflammation can be costly compared with psychological therapies, she said. “Given this, including psychological interventions, such as cost-effective digital interventions, within IBD management might reduce the need for anti-inflammatory medication, resulting in an overall cost benefit.”
The study was funded by the Medical Research Council (MRC) and National Institute for Health and Care Research Maudsley Biomedical Research Centre, which is hosted by South London and Maudsley NHS Foundation Trust in partnership with King’s College London. Ms. Seaton was funded by an MRC Doctoral Training Partnership. No other interests were declared.
A version of this article appeared on Medscape.com.
, according to a new study.
“IBD is a distressing condition, and current medication that reduces inflammation is expensive and can have side effects,” said Natasha Seaton, first author and a PhD student at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London.
“Our study showed that interventions that treat mental health reduce levels of inflammation in the body,” she said. “This indicates that mood interventions could be a valuable tool in our approach to help those with IBD.”
The study was published online in eBioMedicine.
Analyzing Mood Interventions
Ms. Seaton and colleagues conducted a systematic review and meta-analysis of randomized controlled trials in adults with IBD that measured inflammatory biomarker levels and tested a mood intervention, including those aimed at reducing depression, anxiety, stress, or distress or improving emotional well-being.
Looking at data from 28 randomized controlled trials with 1789 participants, the research team evaluated whether mood interventions affected IBD inflammation, particularly IBD indicators such as C-reactive protein and fecal calprotectin, and other general inflammatory biomarkers.
The researchers found mood interventions significantly reduced levels of inflammatory biomarkers, compared with controls, corresponding to an 18% reduction in inflammatory biomarkers.
Psychological therapies had the best outcomes related to IBD inflammation, compared with antidepressants or exercise. These therapies included cognitive behavioral therapy, acceptance and commitment therapy, and mindfulness-based stress reduction.
Individual analyses of IBD-specific inflammatory markers found small but statistically significant reductions in C-reactive protein and fecal calprotectin after a mood intervention. This could mean mood treatments have positive effects on both inflammation and disease-specific biomarkers, the authors wrote.
In addition, interventions that had a larger positive effect on mood had a greater effect in reducing inflammatory biomarkers. This suggests that a better mood could reduce IBD inflammation, they noted.
“We know stress-related feelings can increase inflammation, and the findings suggest that by improving mood, we can reduce this type of inflammation,” said Valeria Mondelli, MD, PhD, clinical professor of psychoneuroimmunology at King’s IoPPN.
“This adds to the growing body of research demonstrating the role of inflammation in mental health and suggests that interventions working to improve mood could also have direct physical effects on levels of inflammation,” she said. “However, more research is needed to understand exact mechanisms in IBD.”
Cost Benefit
Many IBD interventions and medications can be expensive for patients, have significant negative side effects, and have a lower long-term treatment response, the authors noted. Mood interventions, whether psychological therapy or medication, could potentially reduce costs and improve both mood and inflammation.
Previous studies have indicated that psychosocial factors, as well as mood disorders such as anxiety and depression, affect IBD symptom severity and progression, the authors wrote. However, researchers still need to understand the mechanisms behind this connection, including gut-brain dynamics.
Future research should focus on interventions that have been effective at improving mood in patients with IBD, assess inflammation and disease activity at numerous timepoints, and include potential variables related to illness self-management, the authors wrote.
In addition, implementation of mood interventions for IBD management may require better continuity of care and healthcare integration.
“Integrated mental health support, alongside pharmacological treatments, may offer a more holistic approach to IBD care, potentially leading to reduced disease and healthcare costs,” said Rona Moss-Morris, PhD, senior author and professor of psychology at King’s IoPPN.
Medications taken to reduce inflammation can be costly compared with psychological therapies, she said. “Given this, including psychological interventions, such as cost-effective digital interventions, within IBD management might reduce the need for anti-inflammatory medication, resulting in an overall cost benefit.”
The study was funded by the Medical Research Council (MRC) and National Institute for Health and Care Research Maudsley Biomedical Research Centre, which is hosted by South London and Maudsley NHS Foundation Trust in partnership with King’s College London. Ms. Seaton was funded by an MRC Doctoral Training Partnership. No other interests were declared.
A version of this article appeared on Medscape.com.
High Rate of Dementia Among Attendees in Adult Day Service Centers
About one-quarter of all adult day services center (ADSC) participants have dementia, and the prevalence of dementia in ADSCs that specialize in the disorder is more than 40%, a new US National Health Statistics Report revealed.
ADSCs are a growing sector of the US home- and community-based long-term care delivery system, providing daytime services to adults with disabilities who often have multiple chronic conditions, including various types of dementia, according to report authors Priyanka Singha, MPH, and colleagues at the US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics in Bethesda, Maryland.
Dementia often leads to the transition to receiving long-term care services, such as nursing home care. Delaying institutionalization is a primary goal of ADSCs, so they also try to meet the needs of a growing population of community-dwelling adults with dementia.
Survey responses from 1800 ADSCs across the United States showed that overall, 42.2% of participants had dementia in ADSCs specializing in dementia care, while 22.7% of participants in nonspecialized ADSCs also had dementia.
Dementia was more prevalent in the Midwest and West, where nearly one half of participants in specialized centers had dementia.
Nevertheless, the overall prevalence of dementia in ADSCs was similar across US regions, with a slightly lower percentage in the West.
Positive Outcomes
The new report used data from the ADSC component of the 2020 National Post-acute and Long-term Care Study collected from January 2020 through mid-July 2021. About 1800 ADSCs from a census of 5500 ADSCs were included and weighted to be nationally representative.
The authors compared dementia prevalence among participants in ADSCs that provide specialized care for dementia with other ADSCs by census region, metropolitan statistical area (MSA) status, chain affiliation, and ownership type.
MSA is a core urban area population of 50,000 or more. ADSCs that specialize in dementia care have specially trained staff, activities, and facilities. They offer social activities, including art and music therapy, dementia-appropriate games, and group exercises, as well as respite care for unpaid caregivers. The survey found that 14% of ADSCs reported specializing in dementia.
The investigators also found that the percentage of ADSC participants with dementia, regardless of center specialization, was higher in the Midwest (32.1%), Northeast (28.5%), and South (24.5%) than in the West (21.1%).
The percentage of participants with dementia in specialized centers was higher in the Midwest (49.5%) and West (48.8%) than in the Northeast (31.9%) and in nonchain centers (50.5%) than in chain-affiliated centers (30.4%).
In addition, the percentage of participants with dementia, regardless of specialization, was higher in nonchain ADSCs (25%) than in chain-affiliated centers (20.1%). In addition, the percentage of participants with dementia in nonspecialized centers was higher in nonchain centers (25%) than in chain-affiliated centers (20.1%).
Finally, the research revealed that the percentage of participants with dementia, regardless of specialization, was higher in nonprofit ADSCs (28.7%) than for-profit centers (21%).
“These findings indicate that ADSCs in MSAs, nonprofit organizations, and nonchain centers provide services to a higher proportion of participants with dementia, particularly among centers that specialize in dementia care,” the investigators wrote.
Whereas “caregivers manage prescription medications, help with activities of daily living, and offer nutritional diets, exercise, and social engagement, ADSCs play a role in providing this type of care for people with dementia while also offering respite for their unpaid caregivers,” they noted.
Overall, they concluded that ADSCs provide positive outcomes for both family caregivers and people with dementia.
They noted that the study’s limitations include the use of cross-sectional data, which cannot show effectiveness for participants receiving care in specialized centers or be used to analyze relationships between other participant-level sociodemographic or health characteristics and specialized dementia care.
A version of this article appeared on Medscape.com.
About one-quarter of all adult day services center (ADSC) participants have dementia, and the prevalence of dementia in ADSCs that specialize in the disorder is more than 40%, a new US National Health Statistics Report revealed.
ADSCs are a growing sector of the US home- and community-based long-term care delivery system, providing daytime services to adults with disabilities who often have multiple chronic conditions, including various types of dementia, according to report authors Priyanka Singha, MPH, and colleagues at the US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics in Bethesda, Maryland.
Dementia often leads to the transition to receiving long-term care services, such as nursing home care. Delaying institutionalization is a primary goal of ADSCs, so they also try to meet the needs of a growing population of community-dwelling adults with dementia.
Survey responses from 1800 ADSCs across the United States showed that overall, 42.2% of participants had dementia in ADSCs specializing in dementia care, while 22.7% of participants in nonspecialized ADSCs also had dementia.
Dementia was more prevalent in the Midwest and West, where nearly one half of participants in specialized centers had dementia.
Nevertheless, the overall prevalence of dementia in ADSCs was similar across US regions, with a slightly lower percentage in the West.
Positive Outcomes
The new report used data from the ADSC component of the 2020 National Post-acute and Long-term Care Study collected from January 2020 through mid-July 2021. About 1800 ADSCs from a census of 5500 ADSCs were included and weighted to be nationally representative.
The authors compared dementia prevalence among participants in ADSCs that provide specialized care for dementia with other ADSCs by census region, metropolitan statistical area (MSA) status, chain affiliation, and ownership type.
MSA is a core urban area population of 50,000 or more. ADSCs that specialize in dementia care have specially trained staff, activities, and facilities. They offer social activities, including art and music therapy, dementia-appropriate games, and group exercises, as well as respite care for unpaid caregivers. The survey found that 14% of ADSCs reported specializing in dementia.
The investigators also found that the percentage of ADSC participants with dementia, regardless of center specialization, was higher in the Midwest (32.1%), Northeast (28.5%), and South (24.5%) than in the West (21.1%).
The percentage of participants with dementia in specialized centers was higher in the Midwest (49.5%) and West (48.8%) than in the Northeast (31.9%) and in nonchain centers (50.5%) than in chain-affiliated centers (30.4%).
In addition, the percentage of participants with dementia, regardless of specialization, was higher in nonchain ADSCs (25%) than in chain-affiliated centers (20.1%). In addition, the percentage of participants with dementia in nonspecialized centers was higher in nonchain centers (25%) than in chain-affiliated centers (20.1%).
Finally, the research revealed that the percentage of participants with dementia, regardless of specialization, was higher in nonprofit ADSCs (28.7%) than for-profit centers (21%).
“These findings indicate that ADSCs in MSAs, nonprofit organizations, and nonchain centers provide services to a higher proportion of participants with dementia, particularly among centers that specialize in dementia care,” the investigators wrote.
Whereas “caregivers manage prescription medications, help with activities of daily living, and offer nutritional diets, exercise, and social engagement, ADSCs play a role in providing this type of care for people with dementia while also offering respite for their unpaid caregivers,” they noted.
Overall, they concluded that ADSCs provide positive outcomes for both family caregivers and people with dementia.
They noted that the study’s limitations include the use of cross-sectional data, which cannot show effectiveness for participants receiving care in specialized centers or be used to analyze relationships between other participant-level sociodemographic or health characteristics and specialized dementia care.
A version of this article appeared on Medscape.com.
About one-quarter of all adult day services center (ADSC) participants have dementia, and the prevalence of dementia in ADSCs that specialize in the disorder is more than 40%, a new US National Health Statistics Report revealed.
ADSCs are a growing sector of the US home- and community-based long-term care delivery system, providing daytime services to adults with disabilities who often have multiple chronic conditions, including various types of dementia, according to report authors Priyanka Singha, MPH, and colleagues at the US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics in Bethesda, Maryland.
Dementia often leads to the transition to receiving long-term care services, such as nursing home care. Delaying institutionalization is a primary goal of ADSCs, so they also try to meet the needs of a growing population of community-dwelling adults with dementia.
Survey responses from 1800 ADSCs across the United States showed that overall, 42.2% of participants had dementia in ADSCs specializing in dementia care, while 22.7% of participants in nonspecialized ADSCs also had dementia.
Dementia was more prevalent in the Midwest and West, where nearly one half of participants in specialized centers had dementia.
Nevertheless, the overall prevalence of dementia in ADSCs was similar across US regions, with a slightly lower percentage in the West.
Positive Outcomes
The new report used data from the ADSC component of the 2020 National Post-acute and Long-term Care Study collected from January 2020 through mid-July 2021. About 1800 ADSCs from a census of 5500 ADSCs were included and weighted to be nationally representative.
The authors compared dementia prevalence among participants in ADSCs that provide specialized care for dementia with other ADSCs by census region, metropolitan statistical area (MSA) status, chain affiliation, and ownership type.
MSA is a core urban area population of 50,000 or more. ADSCs that specialize in dementia care have specially trained staff, activities, and facilities. They offer social activities, including art and music therapy, dementia-appropriate games, and group exercises, as well as respite care for unpaid caregivers. The survey found that 14% of ADSCs reported specializing in dementia.
The investigators also found that the percentage of ADSC participants with dementia, regardless of center specialization, was higher in the Midwest (32.1%), Northeast (28.5%), and South (24.5%) than in the West (21.1%).
The percentage of participants with dementia in specialized centers was higher in the Midwest (49.5%) and West (48.8%) than in the Northeast (31.9%) and in nonchain centers (50.5%) than in chain-affiliated centers (30.4%).
In addition, the percentage of participants with dementia, regardless of specialization, was higher in nonchain ADSCs (25%) than in chain-affiliated centers (20.1%). In addition, the percentage of participants with dementia in nonspecialized centers was higher in nonchain centers (25%) than in chain-affiliated centers (20.1%).
Finally, the research revealed that the percentage of participants with dementia, regardless of specialization, was higher in nonprofit ADSCs (28.7%) than for-profit centers (21%).
“These findings indicate that ADSCs in MSAs, nonprofit organizations, and nonchain centers provide services to a higher proportion of participants with dementia, particularly among centers that specialize in dementia care,” the investigators wrote.
Whereas “caregivers manage prescription medications, help with activities of daily living, and offer nutritional diets, exercise, and social engagement, ADSCs play a role in providing this type of care for people with dementia while also offering respite for their unpaid caregivers,” they noted.
Overall, they concluded that ADSCs provide positive outcomes for both family caregivers and people with dementia.
They noted that the study’s limitations include the use of cross-sectional data, which cannot show effectiveness for participants receiving care in specialized centers or be used to analyze relationships between other participant-level sociodemographic or health characteristics and specialized dementia care.
A version of this article appeared on Medscape.com.
Youth Mental Health in ‘Dire Straits’
, suggests a new report that shines a light on the global mental health crisis among young people.
The burden is high in this population, with around one-fifth of all disease-related disability attributable to mental disorders. The data, drawn from the 2019 Global Burden of Disease (GBD) study, examines mental health in the 293 million people worldwide in this age group.
“This concentration of disability burden at an early age raises concern about the potential lifetime impact of these conditions,” wrote the authors, led by Christian Kieling, MD, PhD, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
The study was published online in JAMA Psychiatry.
State of Emergency
Soaring rates of mental health disorders among young people, intensified by the COVID-19 pandemic, have led the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics to declare a state of emergency.
Using the GBD study, Dr. Kieling and colleagues estimated the global prevalence and years lived with disability associated with mental disorders and substance use disorders in people aged 5-24 years.
In 2019, individuals in this age range had at least one mental disorder and 31 million had a substance use disorder — an average prevalence of 11.6% and 1.2%, respectively.
The prevalence of mental disorders doubled from the age range of 5-9 years (6.8%) to 20-24 years (13.6%).
Among mental disorders analyzed, anxiety disorders were most common in the overall population (84 million; 3.35%) and schizophrenia the least common (2 million; 0.08%).
Notably, the researchers said, there was a steep increase in mood disorders, particularly anxiety and substance use disorders, across early to late adolescence and from late adolescence to young adulthood.
Mental disorders and substance use disorders were the leading cause of nonfatal disability in children and youths in 2019, accounting for 31 million and 4.3 million years lived with disability (YLDs), respectively. That represents roughly 20% and 3% of YLDs, respectively, from all causes.
Youth Mental Health Is Not a Monolith
“That youth mental health is in such dire straits is particularly striking given that many measures of global physical health in young people are improving,” wrote the authors of an accompanying editorial.
In their editorial, Jeremy Veenstra-VanderWeele, MD, Department of Psychiatry, Columbia University, New York, and co-authors noted that these and other age- and gender-related findings “represent a meaningful contribution to the literature.”
The granular data underscore that youth mental health is “not a monolith” but rather involves considerable variation in prevalence and morbidity across both age and gender, they wrote.
Therefore, mental health screening, promotion, and prevention efforts may benefit from an age-based approach that targets specific disorders during “high prevalence developmental intervals, with keen attention also paid to gender,” they suggested.
On the basis of the findings in this analysis, healthcare and education resource allocation may need to be adjusted for specific disorders, they added.
“One might propose a community- or school-based mental health initiative that screens for and educates parents and teachers on ADHD and anxiety disorders from kindergarten through third grade (ages 5-9 years, when prevalence and resulting disability grow markedly),” Dr. Veenstra-VanderWeele and colleagues wrote. “Later initiatives could then focus on mood and substance use disorders during high school and college (ages 15-19 years and 20-24 years).”
The study was partially funded by a research grant from the Cundill Centre for Child and Youth Depression. Dr. Kieling is the founder of Wida. Dr. Veenstra-VanderWeele reported receiving grants from the National Institutes of Health and Simon’s Foundation and research support/advisory board/editorial fees from Autism Speaks, Agency for Healthcare Research and Quality, Health Resources and Services Administration Maternal and Child Health Bureau, American Academy of Child and Adolescent Psychiatry, Forest, Janssen, Yamo, MapLight, Acadia, Roche, Novartis, Seaside Therapeutics, Springer, SynapDx, and Wiley.
A version of this article appeared on Medscape.com.
, suggests a new report that shines a light on the global mental health crisis among young people.
The burden is high in this population, with around one-fifth of all disease-related disability attributable to mental disorders. The data, drawn from the 2019 Global Burden of Disease (GBD) study, examines mental health in the 293 million people worldwide in this age group.
“This concentration of disability burden at an early age raises concern about the potential lifetime impact of these conditions,” wrote the authors, led by Christian Kieling, MD, PhD, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
The study was published online in JAMA Psychiatry.
State of Emergency
Soaring rates of mental health disorders among young people, intensified by the COVID-19 pandemic, have led the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics to declare a state of emergency.
Using the GBD study, Dr. Kieling and colleagues estimated the global prevalence and years lived with disability associated with mental disorders and substance use disorders in people aged 5-24 years.
In 2019, individuals in this age range had at least one mental disorder and 31 million had a substance use disorder — an average prevalence of 11.6% and 1.2%, respectively.
The prevalence of mental disorders doubled from the age range of 5-9 years (6.8%) to 20-24 years (13.6%).
Among mental disorders analyzed, anxiety disorders were most common in the overall population (84 million; 3.35%) and schizophrenia the least common (2 million; 0.08%).
Notably, the researchers said, there was a steep increase in mood disorders, particularly anxiety and substance use disorders, across early to late adolescence and from late adolescence to young adulthood.
Mental disorders and substance use disorders were the leading cause of nonfatal disability in children and youths in 2019, accounting for 31 million and 4.3 million years lived with disability (YLDs), respectively. That represents roughly 20% and 3% of YLDs, respectively, from all causes.
Youth Mental Health Is Not a Monolith
“That youth mental health is in such dire straits is particularly striking given that many measures of global physical health in young people are improving,” wrote the authors of an accompanying editorial.
In their editorial, Jeremy Veenstra-VanderWeele, MD, Department of Psychiatry, Columbia University, New York, and co-authors noted that these and other age- and gender-related findings “represent a meaningful contribution to the literature.”
The granular data underscore that youth mental health is “not a monolith” but rather involves considerable variation in prevalence and morbidity across both age and gender, they wrote.
Therefore, mental health screening, promotion, and prevention efforts may benefit from an age-based approach that targets specific disorders during “high prevalence developmental intervals, with keen attention also paid to gender,” they suggested.
On the basis of the findings in this analysis, healthcare and education resource allocation may need to be adjusted for specific disorders, they added.
“One might propose a community- or school-based mental health initiative that screens for and educates parents and teachers on ADHD and anxiety disorders from kindergarten through third grade (ages 5-9 years, when prevalence and resulting disability grow markedly),” Dr. Veenstra-VanderWeele and colleagues wrote. “Later initiatives could then focus on mood and substance use disorders during high school and college (ages 15-19 years and 20-24 years).”
The study was partially funded by a research grant from the Cundill Centre for Child and Youth Depression. Dr. Kieling is the founder of Wida. Dr. Veenstra-VanderWeele reported receiving grants from the National Institutes of Health and Simon’s Foundation and research support/advisory board/editorial fees from Autism Speaks, Agency for Healthcare Research and Quality, Health Resources and Services Administration Maternal and Child Health Bureau, American Academy of Child and Adolescent Psychiatry, Forest, Janssen, Yamo, MapLight, Acadia, Roche, Novartis, Seaside Therapeutics, Springer, SynapDx, and Wiley.
A version of this article appeared on Medscape.com.
, suggests a new report that shines a light on the global mental health crisis among young people.
The burden is high in this population, with around one-fifth of all disease-related disability attributable to mental disorders. The data, drawn from the 2019 Global Burden of Disease (GBD) study, examines mental health in the 293 million people worldwide in this age group.
“This concentration of disability burden at an early age raises concern about the potential lifetime impact of these conditions,” wrote the authors, led by Christian Kieling, MD, PhD, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
The study was published online in JAMA Psychiatry.
State of Emergency
Soaring rates of mental health disorders among young people, intensified by the COVID-19 pandemic, have led the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics to declare a state of emergency.
Using the GBD study, Dr. Kieling and colleagues estimated the global prevalence and years lived with disability associated with mental disorders and substance use disorders in people aged 5-24 years.
In 2019, individuals in this age range had at least one mental disorder and 31 million had a substance use disorder — an average prevalence of 11.6% and 1.2%, respectively.
The prevalence of mental disorders doubled from the age range of 5-9 years (6.8%) to 20-24 years (13.6%).
Among mental disorders analyzed, anxiety disorders were most common in the overall population (84 million; 3.35%) and schizophrenia the least common (2 million; 0.08%).
Notably, the researchers said, there was a steep increase in mood disorders, particularly anxiety and substance use disorders, across early to late adolescence and from late adolescence to young adulthood.
Mental disorders and substance use disorders were the leading cause of nonfatal disability in children and youths in 2019, accounting for 31 million and 4.3 million years lived with disability (YLDs), respectively. That represents roughly 20% and 3% of YLDs, respectively, from all causes.
Youth Mental Health Is Not a Monolith
“That youth mental health is in such dire straits is particularly striking given that many measures of global physical health in young people are improving,” wrote the authors of an accompanying editorial.
In their editorial, Jeremy Veenstra-VanderWeele, MD, Department of Psychiatry, Columbia University, New York, and co-authors noted that these and other age- and gender-related findings “represent a meaningful contribution to the literature.”
The granular data underscore that youth mental health is “not a monolith” but rather involves considerable variation in prevalence and morbidity across both age and gender, they wrote.
Therefore, mental health screening, promotion, and prevention efforts may benefit from an age-based approach that targets specific disorders during “high prevalence developmental intervals, with keen attention also paid to gender,” they suggested.
On the basis of the findings in this analysis, healthcare and education resource allocation may need to be adjusted for specific disorders, they added.
“One might propose a community- or school-based mental health initiative that screens for and educates parents and teachers on ADHD and anxiety disorders from kindergarten through third grade (ages 5-9 years, when prevalence and resulting disability grow markedly),” Dr. Veenstra-VanderWeele and colleagues wrote. “Later initiatives could then focus on mood and substance use disorders during high school and college (ages 15-19 years and 20-24 years).”
The study was partially funded by a research grant from the Cundill Centre for Child and Youth Depression. Dr. Kieling is the founder of Wida. Dr. Veenstra-VanderWeele reported receiving grants from the National Institutes of Health and Simon’s Foundation and research support/advisory board/editorial fees from Autism Speaks, Agency for Healthcare Research and Quality, Health Resources and Services Administration Maternal and Child Health Bureau, American Academy of Child and Adolescent Psychiatry, Forest, Janssen, Yamo, MapLight, Acadia, Roche, Novartis, Seaside Therapeutics, Springer, SynapDx, and Wiley.
A version of this article appeared on Medscape.com.
Bariatric Surgery Doesn’t Improve Mental Health in Teens
TOPLINE:
Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.
METHODOLOGY:
- Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
- At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
- A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
- Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
- The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.
TAKEAWAY:
- At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
- The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
- A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
- Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.
IN PRACTICE:
“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.
SOURCE:
Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.
LIMITATIONS:
The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.
DISCLOSURES:
This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.
A version of this article appeared on Medscape.com.
TOPLINE:
Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.
METHODOLOGY:
- Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
- At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
- A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
- Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
- The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.
TAKEAWAY:
- At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
- The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
- A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
- Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.
IN PRACTICE:
“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.
SOURCE:
Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.
LIMITATIONS:
The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.
DISCLOSURES:
This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.
A version of this article appeared on Medscape.com.
TOPLINE:
Adolescents with severe obesity who undergo bariatric surgery may have a continuing need for mental health treatment and an increased risk for alcohol use disorder after the procedure.
METHODOLOGY:
- Researchers evaluated the long-term effects of bariatric surgery on the mental health of 1554 adolescents (75% women) with severe obesity who underwent bariatric surgery in Sweden between 2007 and 2017.
- At the time of surgery, the mean age was 19.0 years, and the mean body mass index was 43.7.
- A general population reference group of 15,540 adolescents was created by matching 10 comparators each to adolescents in the surgery group by age, sex, and country of residence.
- Information on psychiatric healthcare use and filled psychiatric drug prescriptions for 5 years before surgery and the first 10 years after surgery were obtained from national registers.
- The number of visits for self-harm and substance use disorder and the number of filled prescriptions for any psychiatric drug, antidepressants, and anxiolytics were other outcomes of interest.
TAKEAWAY:
- At 5 years before surgery, the prevalence of psychiatric healthcare visits (prevalence difference [Δ], 3.7%) and of psychiatric drug use (Δ, 6.2%) was higher in the surgery vs reference group.
- The preoperative trajectories continued and grew post-surgery, with the differences in psychiatric healthcare visits (Δ, ~12%) and psychiatric drug use (Δ, 20.4%) between the groups peaking at 9 and 10 years post surgery, respectively.
- A low prevalence of healthcare visits for substance use disorder in both groups grew to about 5% of adolescents in the surgery group after 10 years, driven primarily by alcohol use, compared with about 1% of adolescents in the reference group (Δ, 4.3%).
- Surgery is an obesity treatment, leading to sustainable weight loss, cardiometabolic health, and physical quality of life, but mental health improvements cannot be expected at the group level.
IN PRACTICE:
“Adolescent patients should be informed of the increased risk for alcohol use disorder and that they might continue needing mental health treatment,” the authors wrote.
SOURCE:
Gustaf Bruze, PhD, from the Department of Medicine, Clinical Epidemiology Division, Karolinska Institutet, Solna, and Kajsa Jarvholm, PhD, from the Department of Psychology, Lund University, Lund, Sweden, led this study, which was published online in The Lancet Child & Adolescent Health.
LIMITATIONS:
The findings may have limited generalizability to other settings, as the study was performed in Sweden with a predominantly White population undergoing Roux-en-Y gastric bypass in a universally accessible healthcare system. Moreover, there was a shortage of nonsurgically treated adolescents with severe obesity for comparison. Patients undergoing surgery may have easier access to healthcare than the general population, which could account for an increase in healthcare visits.
DISCLOSURES:
This study was supported by the Swedish Research Council and the Swedish Research Council for Health, Working Life, and Welfare. Two authors were the current or previous director of the Scandinavian Obesity Surgery Registry. Several authors declared receiving personal fees, participating in advisory boards and educational activities, and having other ties with Ethicon Johnson & Johnson, and Novo Nordisk.
A version of this article appeared on Medscape.com.
The Solution to a ‘Common and Hazardous’ Symptom of Bipolar Disorder?
. Notably, investigators said, the drug comes without the typical metabolic side effects, including weight gain, associated with this drug class.
A post hoc analysis of pooled data from two trials comparing two different doses of cariprazine (Vraylar) to placebo showed it was consistently effective not only in alleviating bipolar depression but also in improving symptoms of anxiety.
“Since this was a post hoc analysis, one has to be careful about not overstating the findings,” said study investigator Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit.
“But what we can say is that anxiety has been an under-researched, undertreated symptom dimension in BPD, and these findings about cariprazine are very promising,” said Dr. McIntyre, chair and executive director of the Brain and Cognition Discovery Foundation, also in Toronto.
The analysis was published in International Clinical Psychopharmacology) and was presented as a poster at the 2023 Neuroscience Education Institute, Colorado Springs, Colorado.
Ubiquitous, Common, Hazardous
Anxiety in BPD is “ubiquitous, common, and hazardous,” Dr. McIntyre said. “We talk so much about depression and mania as cardinal presentations, but someone could make a case that in that trifecta, we’re missing anxiety.”
In patients with BPD and anxiety, “the index episode is much more difficult to treat, there’s a longer time to remission, lower rates of recovery, and a shorter time to recurrence,” noted Dr. McIntyre, chair of the board of the Depression and Bipolar Support Alliance.
Anxiety also may “represent a portent of other things that can add more to the trouble, like alcohol, illicit drugs, or cannabis use — especially now that cannabis is no longer illegal,” Dr. McIntyre said.
Unfortunately, he said, “there hasn’t been an organized, systematic approach to developing a therapy for anxiety in BPD.” Rather, patients are prescribed benzodiazepines, gabapentinoids, or selective serotonin reuptake inhibitors, all of which have limitations, he added.
Some atypical antipsychotics such as quetiapine have been shown to be helpful with anxiety but “have a lot of baggage and side effects — especially sedation, somnolence, weight gain, and metabolic problems,” Dr. McIntyre noted.
Cariprazine is a dopamine D3-preferring D3/D2 partial agonist, a serotonin 5-HT1A receptor partial agonist, and 5-HT2B receptor antagonist, which has shown anxiolytic-like activity in rodent models.
It was approved by the US Food and Drug Administration to treat mania, depression, and mixed episodes of BPD in 2015 and BPD in 2019.
Dr. McIntyre and his team believed there was an opportunity in the completed randomized controlled trials of cariprazine in BPD to conduct a post hoc analysis of its impact on anxiety.
‘Cornerstone Mood Stabilizer’
The researchers pooled data from two phase 3, randomized, double-blind, placebo-controlled studies in adults with BPD experiencing a current major depressive episode.
The pooled intention-to-treat population consisted of 952 patients with BPD (mean age, ~43 years; 62% female) randomized to receive either 1.5 mg/d, 3 mg/d of cariprazine, or placebo. Patients were divided into two subsets: Lower or higher anxiety (defined as a Hamilton Anxiety Rating Scale [HAM-A] total score of < 18 and ≥ 18, respectively). Patients also completed the Montgomery-Åsberg Rating Scale (MADRS).
A third of the patients received a placebo, a third received the 1.5 mg/d dose, and a third received the 3 mg/d dose. Demographic and baseline characteristics were similar between the subsets.
Results showed there was a statistically significant change in HAM-A total score for cariprazine 1.5 mg/d (P = .0027). The investigators also found a statistically significant change in MADRS total score change for cariprazine 1.5 mg (P = .0200) in the higher anxiety subset. The rate of remission was significantly greater for cariprazine 1.5 mg/d in the higher and lower anxiety subsets (P = .0172 and P = .0004, respectively).
In addition, the change in HAM-A total score change was statistically significant for cariprazine 1.5 mg/d in the higher anxiety subgroup (P = .0105) and the 3 mg/d dose in the lower anxiety subgroup (P = .0441).
Dr. McIntyre hopes these findings can be replicated in other trials.
“Clinically, I find that many patients who take cariprazine don’t require as many benzodiazepines or other medications for anxiety, and it’s one of the better-tolerated medications without metabolic complications or weight gain, so it’s become a cornerstone mood stabilizer,” he said.
Polypharmacy Avoided
Another recent study retrospectively analyzed medical records of close to 40 adult patients with BPD I who were receiving treatment with aripiprazole for bipolar depression and then switched to cariprazine.
“We wanted to conduct a study in depressed patients who had gained weight on aripiprazole and then directly switched to cariprazine. It improved their mood and helped mitigate weight gain, thereby avoiding polypharmacy of additional antidepressants and weight loss agents,” said study investigator Maxwell Zachary Price, a medical student at Hackensack Meridian School of Medicine, Nutley, New Jersey.
“In our general outpatient psychiatry practice, we’ve treated many adult patients with oral aripiprazole for maintenance of BPD,” the study’s senior investigator, Richard Price, MD, clinical assistant professor of psychiatry at Weill Cornell Medical College, New York City, added.
Aripiprazole is associated with weight gain. Moreover, aripiprazole “hasn’t shown efficacy in managing BPD,” he said.
Most patients in Dr. Price’s practice are insured through Medicaid, which mandates treatment with aripiprazole before covering cariprazine. “We noticed their weight had been creeping up over the years, and they also were experiencing depressive symptoms,” he said.
The requirement to initiate treatment with aripiprazole before switching to cariprazine offered Dr. Price an opportunity to compare the two agents in this real-world setting by retrospectively reviewing the charts of 37 patients with BPD (23 females and 14 males who made the switch). The patients had been taking aripiprazole for a mean duration of 94.9 weeks and had experienced a mean increase in body weight of 16.1% ± 12.3% on aripiprazole before switching.
Patients who were taking 2 mg-10 mg of aripiprazole were switched to 1.5 mg of cariprazine, while those taking ≥ 15 mg of aripiprazole were switched to 3 mg of cariprazine.
“Patients tolerated the switch well and maintained stability during the transition,” and “no patients discontinued cariprazine during the study,” Dr. Price said.
After a mean duration of 36.7 weeks (range, 1-127 weeks), the patients showed a decrease in Clinical Global Impression-Bipolar Severity of Illness Scale score from a mean of 5.0 ± 0.9 to a mean of 2.8 ± 0.7 (t = −12.75, P < .00001).
The patients’ weight dropped from a mean of 90.3± 21.5 kg on aripiprazole to a mean of 83.9 ± 19.2 kg on cariprazine (t = −4.22, P < .001).
Two patients experienced initial nausea that resolved by taking the medication with food, and two experienced initial restlessness that resolved with dosage reduction.
“We found that the patients were lighter in mood, body habitus and weight, and less agitated and their mental alertness and concentration improved as well,” said Dr. Price. He hopes that further research in randomized blinded trials will corroborate the findings.
Hypothesis-Generating Research
Joseph Cerimele, MD, MPH, associate professor of psychiatry and behavioral sciences, University of Washington, Division of Population Health, UW Medicine, Seattle, Washington, said the research findings are “hypothesis-generating.”
Dr. Ciremele, who wasn’t involved with either study, said many clinicians and researchers are trying to tailor treatment options to match patient characteristics, and these studies and other similar research, “help us all ask questions related to concurrent symptoms in bipolar depression.”
However, the post hoc analysis was a secondary analysis of an efficacy trial where individuals with concurrent anxiety disorders were excluded. “So, a next step might be to evaluate this and other treatments in individuals with BPD and concurrent anxiety disorders,” he said.
The study by Jain et al was funded by AbbVie. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics Inc., Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies, NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. Dr. McIntyre is the CEO of Braxia Scientific Corp. His coauthors’ disclosures are listed in the original paper. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Mr. Price and Dr. Cerimele reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
. Notably, investigators said, the drug comes without the typical metabolic side effects, including weight gain, associated with this drug class.
A post hoc analysis of pooled data from two trials comparing two different doses of cariprazine (Vraylar) to placebo showed it was consistently effective not only in alleviating bipolar depression but also in improving symptoms of anxiety.
“Since this was a post hoc analysis, one has to be careful about not overstating the findings,” said study investigator Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit.
“But what we can say is that anxiety has been an under-researched, undertreated symptom dimension in BPD, and these findings about cariprazine are very promising,” said Dr. McIntyre, chair and executive director of the Brain and Cognition Discovery Foundation, also in Toronto.
The analysis was published in International Clinical Psychopharmacology) and was presented as a poster at the 2023 Neuroscience Education Institute, Colorado Springs, Colorado.
Ubiquitous, Common, Hazardous
Anxiety in BPD is “ubiquitous, common, and hazardous,” Dr. McIntyre said. “We talk so much about depression and mania as cardinal presentations, but someone could make a case that in that trifecta, we’re missing anxiety.”
In patients with BPD and anxiety, “the index episode is much more difficult to treat, there’s a longer time to remission, lower rates of recovery, and a shorter time to recurrence,” noted Dr. McIntyre, chair of the board of the Depression and Bipolar Support Alliance.
Anxiety also may “represent a portent of other things that can add more to the trouble, like alcohol, illicit drugs, or cannabis use — especially now that cannabis is no longer illegal,” Dr. McIntyre said.
Unfortunately, he said, “there hasn’t been an organized, systematic approach to developing a therapy for anxiety in BPD.” Rather, patients are prescribed benzodiazepines, gabapentinoids, or selective serotonin reuptake inhibitors, all of which have limitations, he added.
Some atypical antipsychotics such as quetiapine have been shown to be helpful with anxiety but “have a lot of baggage and side effects — especially sedation, somnolence, weight gain, and metabolic problems,” Dr. McIntyre noted.
Cariprazine is a dopamine D3-preferring D3/D2 partial agonist, a serotonin 5-HT1A receptor partial agonist, and 5-HT2B receptor antagonist, which has shown anxiolytic-like activity in rodent models.
It was approved by the US Food and Drug Administration to treat mania, depression, and mixed episodes of BPD in 2015 and BPD in 2019.
Dr. McIntyre and his team believed there was an opportunity in the completed randomized controlled trials of cariprazine in BPD to conduct a post hoc analysis of its impact on anxiety.
‘Cornerstone Mood Stabilizer’
The researchers pooled data from two phase 3, randomized, double-blind, placebo-controlled studies in adults with BPD experiencing a current major depressive episode.
The pooled intention-to-treat population consisted of 952 patients with BPD (mean age, ~43 years; 62% female) randomized to receive either 1.5 mg/d, 3 mg/d of cariprazine, or placebo. Patients were divided into two subsets: Lower or higher anxiety (defined as a Hamilton Anxiety Rating Scale [HAM-A] total score of < 18 and ≥ 18, respectively). Patients also completed the Montgomery-Åsberg Rating Scale (MADRS).
A third of the patients received a placebo, a third received the 1.5 mg/d dose, and a third received the 3 mg/d dose. Demographic and baseline characteristics were similar between the subsets.
Results showed there was a statistically significant change in HAM-A total score for cariprazine 1.5 mg/d (P = .0027). The investigators also found a statistically significant change in MADRS total score change for cariprazine 1.5 mg (P = .0200) in the higher anxiety subset. The rate of remission was significantly greater for cariprazine 1.5 mg/d in the higher and lower anxiety subsets (P = .0172 and P = .0004, respectively).
In addition, the change in HAM-A total score change was statistically significant for cariprazine 1.5 mg/d in the higher anxiety subgroup (P = .0105) and the 3 mg/d dose in the lower anxiety subgroup (P = .0441).
Dr. McIntyre hopes these findings can be replicated in other trials.
“Clinically, I find that many patients who take cariprazine don’t require as many benzodiazepines or other medications for anxiety, and it’s one of the better-tolerated medications without metabolic complications or weight gain, so it’s become a cornerstone mood stabilizer,” he said.
Polypharmacy Avoided
Another recent study retrospectively analyzed medical records of close to 40 adult patients with BPD I who were receiving treatment with aripiprazole for bipolar depression and then switched to cariprazine.
“We wanted to conduct a study in depressed patients who had gained weight on aripiprazole and then directly switched to cariprazine. It improved their mood and helped mitigate weight gain, thereby avoiding polypharmacy of additional antidepressants and weight loss agents,” said study investigator Maxwell Zachary Price, a medical student at Hackensack Meridian School of Medicine, Nutley, New Jersey.
“In our general outpatient psychiatry practice, we’ve treated many adult patients with oral aripiprazole for maintenance of BPD,” the study’s senior investigator, Richard Price, MD, clinical assistant professor of psychiatry at Weill Cornell Medical College, New York City, added.
Aripiprazole is associated with weight gain. Moreover, aripiprazole “hasn’t shown efficacy in managing BPD,” he said.
Most patients in Dr. Price’s practice are insured through Medicaid, which mandates treatment with aripiprazole before covering cariprazine. “We noticed their weight had been creeping up over the years, and they also were experiencing depressive symptoms,” he said.
The requirement to initiate treatment with aripiprazole before switching to cariprazine offered Dr. Price an opportunity to compare the two agents in this real-world setting by retrospectively reviewing the charts of 37 patients with BPD (23 females and 14 males who made the switch). The patients had been taking aripiprazole for a mean duration of 94.9 weeks and had experienced a mean increase in body weight of 16.1% ± 12.3% on aripiprazole before switching.
Patients who were taking 2 mg-10 mg of aripiprazole were switched to 1.5 mg of cariprazine, while those taking ≥ 15 mg of aripiprazole were switched to 3 mg of cariprazine.
“Patients tolerated the switch well and maintained stability during the transition,” and “no patients discontinued cariprazine during the study,” Dr. Price said.
After a mean duration of 36.7 weeks (range, 1-127 weeks), the patients showed a decrease in Clinical Global Impression-Bipolar Severity of Illness Scale score from a mean of 5.0 ± 0.9 to a mean of 2.8 ± 0.7 (t = −12.75, P < .00001).
The patients’ weight dropped from a mean of 90.3± 21.5 kg on aripiprazole to a mean of 83.9 ± 19.2 kg on cariprazine (t = −4.22, P < .001).
Two patients experienced initial nausea that resolved by taking the medication with food, and two experienced initial restlessness that resolved with dosage reduction.
“We found that the patients were lighter in mood, body habitus and weight, and less agitated and their mental alertness and concentration improved as well,” said Dr. Price. He hopes that further research in randomized blinded trials will corroborate the findings.
Hypothesis-Generating Research
Joseph Cerimele, MD, MPH, associate professor of psychiatry and behavioral sciences, University of Washington, Division of Population Health, UW Medicine, Seattle, Washington, said the research findings are “hypothesis-generating.”
Dr. Ciremele, who wasn’t involved with either study, said many clinicians and researchers are trying to tailor treatment options to match patient characteristics, and these studies and other similar research, “help us all ask questions related to concurrent symptoms in bipolar depression.”
However, the post hoc analysis was a secondary analysis of an efficacy trial where individuals with concurrent anxiety disorders were excluded. “So, a next step might be to evaluate this and other treatments in individuals with BPD and concurrent anxiety disorders,” he said.
The study by Jain et al was funded by AbbVie. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics Inc., Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies, NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. Dr. McIntyre is the CEO of Braxia Scientific Corp. His coauthors’ disclosures are listed in the original paper. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Mr. Price and Dr. Cerimele reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
. Notably, investigators said, the drug comes without the typical metabolic side effects, including weight gain, associated with this drug class.
A post hoc analysis of pooled data from two trials comparing two different doses of cariprazine (Vraylar) to placebo showed it was consistently effective not only in alleviating bipolar depression but also in improving symptoms of anxiety.
“Since this was a post hoc analysis, one has to be careful about not overstating the findings,” said study investigator Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, and head of the Mood Disorders Psychopharmacology Unit.
“But what we can say is that anxiety has been an under-researched, undertreated symptom dimension in BPD, and these findings about cariprazine are very promising,” said Dr. McIntyre, chair and executive director of the Brain and Cognition Discovery Foundation, also in Toronto.
The analysis was published in International Clinical Psychopharmacology) and was presented as a poster at the 2023 Neuroscience Education Institute, Colorado Springs, Colorado.
Ubiquitous, Common, Hazardous
Anxiety in BPD is “ubiquitous, common, and hazardous,” Dr. McIntyre said. “We talk so much about depression and mania as cardinal presentations, but someone could make a case that in that trifecta, we’re missing anxiety.”
In patients with BPD and anxiety, “the index episode is much more difficult to treat, there’s a longer time to remission, lower rates of recovery, and a shorter time to recurrence,” noted Dr. McIntyre, chair of the board of the Depression and Bipolar Support Alliance.
Anxiety also may “represent a portent of other things that can add more to the trouble, like alcohol, illicit drugs, or cannabis use — especially now that cannabis is no longer illegal,” Dr. McIntyre said.
Unfortunately, he said, “there hasn’t been an organized, systematic approach to developing a therapy for anxiety in BPD.” Rather, patients are prescribed benzodiazepines, gabapentinoids, or selective serotonin reuptake inhibitors, all of which have limitations, he added.
Some atypical antipsychotics such as quetiapine have been shown to be helpful with anxiety but “have a lot of baggage and side effects — especially sedation, somnolence, weight gain, and metabolic problems,” Dr. McIntyre noted.
Cariprazine is a dopamine D3-preferring D3/D2 partial agonist, a serotonin 5-HT1A receptor partial agonist, and 5-HT2B receptor antagonist, which has shown anxiolytic-like activity in rodent models.
It was approved by the US Food and Drug Administration to treat mania, depression, and mixed episodes of BPD in 2015 and BPD in 2019.
Dr. McIntyre and his team believed there was an opportunity in the completed randomized controlled trials of cariprazine in BPD to conduct a post hoc analysis of its impact on anxiety.
‘Cornerstone Mood Stabilizer’
The researchers pooled data from two phase 3, randomized, double-blind, placebo-controlled studies in adults with BPD experiencing a current major depressive episode.
The pooled intention-to-treat population consisted of 952 patients with BPD (mean age, ~43 years; 62% female) randomized to receive either 1.5 mg/d, 3 mg/d of cariprazine, or placebo. Patients were divided into two subsets: Lower or higher anxiety (defined as a Hamilton Anxiety Rating Scale [HAM-A] total score of < 18 and ≥ 18, respectively). Patients also completed the Montgomery-Åsberg Rating Scale (MADRS).
A third of the patients received a placebo, a third received the 1.5 mg/d dose, and a third received the 3 mg/d dose. Demographic and baseline characteristics were similar between the subsets.
Results showed there was a statistically significant change in HAM-A total score for cariprazine 1.5 mg/d (P = .0027). The investigators also found a statistically significant change in MADRS total score change for cariprazine 1.5 mg (P = .0200) in the higher anxiety subset. The rate of remission was significantly greater for cariprazine 1.5 mg/d in the higher and lower anxiety subsets (P = .0172 and P = .0004, respectively).
In addition, the change in HAM-A total score change was statistically significant for cariprazine 1.5 mg/d in the higher anxiety subgroup (P = .0105) and the 3 mg/d dose in the lower anxiety subgroup (P = .0441).
Dr. McIntyre hopes these findings can be replicated in other trials.
“Clinically, I find that many patients who take cariprazine don’t require as many benzodiazepines or other medications for anxiety, and it’s one of the better-tolerated medications without metabolic complications or weight gain, so it’s become a cornerstone mood stabilizer,” he said.
Polypharmacy Avoided
Another recent study retrospectively analyzed medical records of close to 40 adult patients with BPD I who were receiving treatment with aripiprazole for bipolar depression and then switched to cariprazine.
“We wanted to conduct a study in depressed patients who had gained weight on aripiprazole and then directly switched to cariprazine. It improved their mood and helped mitigate weight gain, thereby avoiding polypharmacy of additional antidepressants and weight loss agents,” said study investigator Maxwell Zachary Price, a medical student at Hackensack Meridian School of Medicine, Nutley, New Jersey.
“In our general outpatient psychiatry practice, we’ve treated many adult patients with oral aripiprazole for maintenance of BPD,” the study’s senior investigator, Richard Price, MD, clinical assistant professor of psychiatry at Weill Cornell Medical College, New York City, added.
Aripiprazole is associated with weight gain. Moreover, aripiprazole “hasn’t shown efficacy in managing BPD,” he said.
Most patients in Dr. Price’s practice are insured through Medicaid, which mandates treatment with aripiprazole before covering cariprazine. “We noticed their weight had been creeping up over the years, and they also were experiencing depressive symptoms,” he said.
The requirement to initiate treatment with aripiprazole before switching to cariprazine offered Dr. Price an opportunity to compare the two agents in this real-world setting by retrospectively reviewing the charts of 37 patients with BPD (23 females and 14 males who made the switch). The patients had been taking aripiprazole for a mean duration of 94.9 weeks and had experienced a mean increase in body weight of 16.1% ± 12.3% on aripiprazole before switching.
Patients who were taking 2 mg-10 mg of aripiprazole were switched to 1.5 mg of cariprazine, while those taking ≥ 15 mg of aripiprazole were switched to 3 mg of cariprazine.
“Patients tolerated the switch well and maintained stability during the transition,” and “no patients discontinued cariprazine during the study,” Dr. Price said.
After a mean duration of 36.7 weeks (range, 1-127 weeks), the patients showed a decrease in Clinical Global Impression-Bipolar Severity of Illness Scale score from a mean of 5.0 ± 0.9 to a mean of 2.8 ± 0.7 (t = −12.75, P < .00001).
The patients’ weight dropped from a mean of 90.3± 21.5 kg on aripiprazole to a mean of 83.9 ± 19.2 kg on cariprazine (t = −4.22, P < .001).
Two patients experienced initial nausea that resolved by taking the medication with food, and two experienced initial restlessness that resolved with dosage reduction.
“We found that the patients were lighter in mood, body habitus and weight, and less agitated and their mental alertness and concentration improved as well,” said Dr. Price. He hopes that further research in randomized blinded trials will corroborate the findings.
Hypothesis-Generating Research
Joseph Cerimele, MD, MPH, associate professor of psychiatry and behavioral sciences, University of Washington, Division of Population Health, UW Medicine, Seattle, Washington, said the research findings are “hypothesis-generating.”
Dr. Ciremele, who wasn’t involved with either study, said many clinicians and researchers are trying to tailor treatment options to match patient characteristics, and these studies and other similar research, “help us all ask questions related to concurrent symptoms in bipolar depression.”
However, the post hoc analysis was a secondary analysis of an efficacy trial where individuals with concurrent anxiety disorders were excluded. “So, a next step might be to evaluate this and other treatments in individuals with BPD and concurrent anxiety disorders,” he said.
The study by Jain et al was funded by AbbVie. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics Inc., Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies, NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. Dr. McIntyre is the CEO of Braxia Scientific Corp. His coauthors’ disclosures are listed in the original paper. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus. Mr. Price and Dr. Cerimele reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Schizophrenia Med Safe, Effective for Bipolar Mania: Phase 3 Data
Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.
The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.
“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.
The study was published online in the Journal of Clinical Psychiatry.
Early Improvement
Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.
The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).
Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.
The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).
Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).
Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.
Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
Favorable Akathisia Profile
As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.
Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.
The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).
Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.
Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.
Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”
Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.
One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
Potential Second-Line Treatment
Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.
“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.
Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT2A and dopamine D2 and D3 receptors, as well as the noradrenergic α1 receptors.
The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.
Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.
“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.
This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.
A version of this article appeared on Medscape.com.
Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.
The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.
“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.
The study was published online in the Journal of Clinical Psychiatry.
Early Improvement
Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.
The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).
Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.
The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).
Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).
Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.
Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
Favorable Akathisia Profile
As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.
Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.
The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).
Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.
Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.
Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”
Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.
One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
Potential Second-Line Treatment
Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.
“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.
Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT2A and dopamine D2 and D3 receptors, as well as the noradrenergic α1 receptors.
The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.
Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.
“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.
This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.
A version of this article appeared on Medscape.com.
Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.
The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.
“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.
The study was published online in the Journal of Clinical Psychiatry.
Early Improvement
Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.
The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).
Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.
The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).
Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).
Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.
Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
Favorable Akathisia Profile
As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.
Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.
The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).
Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.
Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.
Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”
Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.
One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
Potential Second-Line Treatment
Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.
“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.
Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT2A and dopamine D2 and D3 receptors, as well as the noradrenergic α1 receptors.
The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.
Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.
“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.
This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.
A version of this article appeared on Medscape.com.