Major Depressive Disorder

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Determining whether patients are fatigued or experiencing sleepiness is an important criterion when diagnosing hypersomnia, according to Ruth M. Benca, MD, PhD.

©Digitial Vision/Thinkstockphotos.com

Treatments for hypersomnia

The first priority for patients with hypersomnia is to avoid sleep deprivation and practice good sleep hygiene – factors that are important both in insomnia and hypersomnia. “Make sure that patients are having adequate time in bed and having regular hours of sleep,” Dr. Benca said.

For patients with comorbid psychiatric, medical and sleep disorders, focus on getting rid of medications that may cause sleepiness, including sedating medications and antidepressants, and consider using stimulants if appropriate. While there are Food and Drug Administration–approved medications for narcolepsy and some are approved for hypersomnia in patients with obstructive sleep apnea (OSA), none are officially approved to treat hypersomnia in psychiatric patients.

“Whenever we use these drugs for those reasons, we’re using them off label,” Dr. Benca said.

Modafinil/armodafinil, approved for narcolepsy, shift-work disorder, and OSA in Ehlers-Danlos syndrome, is one off-label option for patients with hypersomnia. “They are lower potency and less addictive than the amphetamines, [with] fewer side effects,” Dr. Benca explained, but should be prescribed with caution in some women because of potential reduced efficacy of oral contraceptives. Side effects of modafinil include headache, nausea, eosinophilia, diarrhea, dry mouth, and anorexia.

Methylphenidate is another option for hypersomnia, available in racemic mixture, pure D-isomer, and time-release formulations.

Patients taking methylphenidate may experience nervousness, insomnia, anorexia, nausea, dizziness, hypertension, hypotension, hypersensitivity reactions, tachycardia, and headache as side effects.

For patients with central nervous system hypersomnias, amphetamines can be used, with methamphetamines having a “very similar profile” and similar side effects, including insomnia, restlessness, tachycardia, dizziness, diarrhea, constipation, hypertension, impotence, and rare cases of psychotic episodes.

Practice parameters released by the American Academy of Sleep Medicine in 2007 suggest that modafinil may have efficacy in idiopathic hypersomnia, Parkinson’s disease, myotonic dystrophy, and multiple sclerosis. The practice parameters also suggest hypersomnias of central origin can be treated with modafinil, amphetamine, methamphetamine, dextroamphetamine, and methylphenidate based on evidence or “long history of use” (Sleep. 2007;30:1705-11).

“Interestingly, there is no mention of psychiatric disorders in these practice parameters, and they report that there are mixed results using stimulants off label for sleepiness and fatigue in traumatic brain injury and poststroke fatigue,” Dr. Benca said.

Dr. Benca reported that she is a consultant to Eisai, Idorsia, Jazz, Merck, and Sunovion. Global Academy and this news organization are owned by the same parent company.

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Psilocybin, the psychedelic compound in “magic mushrooms,” rapidly improves symptoms and produces remission in as little as two sessions for patients with major depression, new research suggests.

Results of a small randomized trial showed that treatment with psilocybin was associated with a greater than 50% reduction in depressive symptoms in 67% of study participants. In addition, 71% showed improvement at 4-week follow-up, with more than 50% achieving remission.

“The finding that the majority of people whom we treated showed efficacy was quite a remarkable and gratifying finding and really sets the stage for psilocybin as a treatment for major depression,” senior investigator Roland Griffiths, PhD, Oliver Lee McCabe III Professor in the Neuropsychopharmacology of Consciousness, Johns Hopkins University, Baltimore, said in a statement.

“Perhaps the most exciting aspect of this as a new therapy is that psilocybin works as a therapeutic intervention with a single session or a few sessions, and then the effects are enduring. In contrast, most conventional treatments for depression ... are given chronically and also have chronic side effects,” added Dr. Griffiths, who is also director of the Johns Hopkins Center for Psychedelic and Consciousness Research.

The study was published online Nov.4 in JAMA Psychiatry.
 

Growing evidence base

As previously reported, psilocybin improves depressive symptoms for patients with cancer. However, these patients might be regarded as having a “reactive depression” to their life-threatening illness, said Dr. Griffiths.

“This study built on that previous research by asking the question, is psilocybin effective in patients who have major depressive disorder, [which is] a much larger population?” he said.

In addition, prior studies of psilocybin-assisted therapy had no control group, lead author Alan Davis, PhD, adjunct assistant professor in the psychedelic research unit, Johns Hopkins University, said in an interview.

The researchers created a control condition by randomly assigning 24 individuals (mean age, 39.8 years; 67% women) who were currently experiencing a moderate or severe major depressive episode to receive either immediate treatment (IT) (n = 13) or delayed treatment (DT) (n = 11).

Participants had longstanding depression, with a mean of 22.4 months in the current depressive episode. They were required to avoid using other antidepressants for 4 weeks prior to screening and up to 4 months following enrollment.

Patients were also required to be medically stable; have no personal/family history of psychotic or bipolar disorders; no past-year alcohol, substance, or nicotine use disorder; and no substantial lifetime or recent use of ketamine or classic hallucinogens.

Depression was measured using the Structured Clinical Interview for DSM-5 and the GRID-Hamilton Depression Rating Scale (GRID-HAMD). A baseline score of ≥17 was required for enrollment.

Participants received eight preparatory meetings with two session facilitators before the first psilocybin session and then 2-3 hours of follow-up meetings after the psilocybin sessions. In addition, they received 13 sessions of psychotherapy.

After completing these preparatory sessions, they underwent two psilocybin sessions, administered a mean of 1.6 weeks apart.

Participants in the DT group were assessed for depressive symptoms weekly for 8 weeks prior to entering the treatment protocol.
 

‘Surprising’ findings

Participants in the IT group exhibited significantly lower depression scores on the GRID-HAMD at 1 and 4 weeks after the second psilocybin session in comparison with patients in the DT group during the corresponding weeks.

Moreover, the effect sizes at weeks 5 and 8 were “large” (d = 2.2; 95% confidence interval, 1.4-3.0; and d = 2.6; 95% CI, 1.7-3.6, respectively).

An analysis of outcomes showed that, for all 24 participants, at 1 and at 4 weeks following the psilocybin intervention, 67% and 71% of participants, respectively, had a “clinically significant response” in depressive symptoms; 60% and 56%, respectively, met criteria for remission.

Within-subject T tests likewise revealed significant decreases in depression scores from baseline to 1- and 4-week follow-ups (P < .001; d = 3.6; 95% CI, 2.2-5.0; and P < .001; d = 3.6; 95% CI, 2.2-4.9, respectively).

Importantly, participants experienced no serious adverse effects.

Dr. Griffiths said he was “surprised” by the findings. “We knew that psilocybin would be effective in reactive depression of the type associated with illness, but we did not know that this would be the case in the large number of individuals who qualify for having [major depressive disorder].”

Dr. Davis said the finding “represents a large effect of this treatment among people with major depressive disorder – an approximately 4 times larger effect, compared to studies of antidepressant drugs.”

Dr. Davis noted that psychotherapy was an “essential” component of the study protocol. “It is likely that the combination of psychotherapy and psilocybin is what makes this treatment efficacious and that this treatment will always have a psychotherapy component and will not be Food and Drug Administration approved as a standalone medication.”

Tipping point

Collin Reiff, MD, clinical assistant professor in the department of psychiatry at New York University noted that because psychedelics are “still stigmatized,” the publication of this study in “one of the highest-impact journals in all of psychiatry suggests that research into psychedelics is now in the mainstream and that the academic psychiatry research community is paying close attention to what is happening.” He described this as a “tipping point.”

Dr. Reiff, who was not involved with the study, noted that research had been conducted on psychedelic compounds until the 1960s, “when they left the research lab and went mainstream, leading to the shutting down and subsequent dormancy of the research for the next 30-40 years.”

Psychedelic research is “undergoing a renaissance and no longer regarded with as much skepticism, but it is important to take our time doing this research so we do not repeat what happened in the 1960s,” said Dr. Reiff.

In an accompanying editorial, Charles F. Reynolds III, MD, endowed professor in geriatric psychiatry at the University of Pittsburgh Medical Center, Pennsylvania, questioned “for whom psychedelic-assisted psychotherapy is appropriate (or not), particularly in patients with depression who are suicidal of have a history of suicide attempt.”

Dr. Reynolds, who is also director of the Aging Institute of UPMC, who was not involved with the study, wrote that “personalizing the management of depression has to entail an understanding of the multiple contexts in which depression occurs, including genetic, developmental, psychosocial, cultural, medical, neurocognitive, and spiritual.”

The study was supported by a crowdsourcing campaign organized by Tim Ferris, as well as by grants from the Riverstyx Foundation. The Center for Psychedelic and Consciousness Research is funded by the Steven and Alexandra Cohen Foundation and receives support from Tim Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie. It is also supported by grants from the National Institute on Drug Abuse. Dr. Davis received support from the NIDA. Dr. Griffiths was partially supported by a NIDA grant. Disclosures for the other authors are listed in the original article. Reiff reports owning stock in Compass Pathways. Dr. Reynolds reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.

“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.

SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.

Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.

Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.

“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.

SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.

Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.

Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.

“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.

SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.

Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.

The COVID-19 pandemic is one of the most pressing public health challenges the United States has ever faced, and the resulting financial ruin and social isolation are creating a mental health pandemic that will continue well after COVID-19 lockdowns end. This mental health fallout may surpass the destruction from the virus with regard to disease, death, and distress. To understand which presidential candidate would best lead the mental health recovery, we identified three of the most critical issues in mental health and compared the plans of the two candidates.

Fighting the opioid epidemic

Over the last several years, the opioid epidemic has devastated American families and communities. Prior to the pandemic, drug overdoses were the leading cause of death for American adults under 50 years of age. The effects of COVID-19–enabled overdose deaths to rise even higher. Multiple elements of the pandemic – isolation, unemployment, and increased anxiety and depression – make those struggling with substance use even more vulnerable, and immediate and comprehensive action is needed to address this national tragedy.

Donald J. Trump: President Trump has been vocal and active in addressing this problem since he took office. One of the Trump administration’s successes is launching the Opioid and Drug Abuse Commission and rolling out a five-point strategy built around improving services, data, research, overdose-reversing drugs, and pain management. Last year, the Trump administration funded $10 billion over 5 years to combat both the opioid epidemic and mental health issues by building upon the 21st Century CURES Act. However, in this same budget, the administration proposed cutting funding by $600 million for SAMHSA, the Substance Abuse and Mental Health Services Administration, which is the top government agency for addressing and providing care for substance use.

President Trump also created an assistant secretary for mental health and substance use position in the Department of Health & Human Services, and appointed Elinore F. McCance-Katz, MD, PhD, a psychiatrist with a strong track record on fighting opioid abuse in Rhode Island, to the post.
 

Joe Biden: Former Vice President Biden emphasizes that substance use is “a disease of the brain,” refuting the long-held misconception that addiction is an issue of willpower. This stigmatization is very personal given that his own son Hunter reportedly suffered through mental health and substance use issues since his teenage years. However, Biden also had a major role in pushing forward the federal “war on drugs,” including his role in crafting the “Len Bias law.”

Mr. Biden has since released a multifaceted plan for reducing substance use, aiming to make prevention and treatment services more available through a $125 billion federal investment. There are also measures to hold pharmaceutical companies accountable for triggering the crisis, stop the flow of fentanyl to the United States, and restrict incentive payments from manufacturers to doctors so as to limit the dosing and usage of powerful opioids.
 

Accessing health care

One of the main dividing lines in this election has been the battle to either gut or build upon the Affordable Care Act (ACA). This will have deep ramifications on people’s access to health mental health services. Since COVID-19 started, more than 50% of Americans have reported worsening mental health. This makes it crucial that each candidate’s mental health plan is judged by how they would expand access to insurance, address unenforced parity laws, and protect those who have a mental health disorder as a preexisting condition.

Mr. Trump: Following a failed Senate vote to repeal this law, the Trump administration took a piecemeal approach to dismantling the ACA that included removing the individual mandate, enabling states to introduce Medicaid work requirements, and reducing cost-sharing subsidies to insurers.

If a re-elected Trump administration pursued a complete repeal of the ACA law, many individuals with previous access to mental health and substance abuse treatment via Medicaid expansion may lose access altogether. In addition, key mechanisms aimed at making sure that mental health services are covered by private health plans may be lost, which could undermine policies to address opioids and suicide. On the other hand, the Trump administration’s move during the pandemic to expand telemedicine services has also expanded access to mental health services.

Mr. Biden: Mr. Biden’s plan would build upon the ACA by working to achieve parity between the treatment of mental health and physical health. The ACA itself strengthened the Mental Health Parity and Addiction Equity Act (federal parity law), which Mr. Biden championed as vice president, by mandating that all private insurance cover mental health and substance abuse treatment. This act still exempts some health plans, such as larger employers; and many insurers have used loopholes in the policy to illegally deny what could be life-saving coverage.

It follows that those who can afford Mr. Biden’s proposed public option Medicare buy-in would receive more comprehensive mental health benefits. He also says he would invest in school and college mental health professionals, an important opportunity for early intervention given 75% of lifetime mental illness starts by age 24 years. While Mr. Biden has not stated a specific plan for addressing minority groups, whose mental health has been disproportionately affected by COVID-19, he has acknowledged that this unmet need should be targeted.
 

Addressing suicide

More than 3,000 Americans attempt suicide every day. Suicide is the second leading cause of death for America’s youth and one of the top 10 leading causes of death across the population. Numerous strategies are necessary to address suicide, but one of the most decisive is gun control. Gun violence is inextricably tied to suicide: States where gun prevalence is higher see about four times the number of suicides because of guns, whereas nonfirearm suicide rates are the same as those seen elsewhere. In 2017, of the nearly 40,000 people who died of gun violence, 60% were attributable to suicides. Since the pandemic started, there have been increases in reported suicidal thoughts and a nearly 1,000% increase in use of the national crisis hotline. This is especially concerning given the uptick during the pandemic of gun purchases; as of September, more guns have been purchased this year than any year before.

Mr. Trump: Prior to coronavirus, the Trump administration was unwilling to enact gun control legislation. In early 2017, Mr. Trump removed an Obama-era bill that would have expanded the background check database. It would have added those deemed legally unfit to handle their own funds and those who received Social Security funds for mental health reasons. During the lockdown, the administration made an advisory ruling declaring gun shops as essential businesses that states should keep open.

Mr. Biden: The former vice president has a history of supporting gun control measures in his time as a senator and vice president. In the Senate, Mr. Biden supported both the Brady handgun bill in 1993 and a ban on assault weapons in 1994. As vice president, he was tasked by President Obama to push for a renewed assault weapons ban and a background check bill (Manchin-Toomey bill).

During his 2020 presidential campaign, Mr. Biden has suggested creating universal background checks and reinstating bans on assault rifle sales. He has said that he is also open to having a federal buyback program for assault rifles from gun owners.
 

Why this matters

The winner of the 2020 election will lead an electorate that is reeling from the health, economic, and social consequences COVID-19. The next administration needs to act swiftly to address the mental health pandemic and have a keen awareness of what is ahead. As Americans make their voting decision, consider who has the best plans not only to contain the virus but also the mental health crises that are ravaging our nation.

Dr. Vasan is a clinical assistant professor of psychiatry at Stanford (Calif.) University, where she is founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation. She also serves as chief medical officer of Real, and chair of the American Psychiatric Association Committee on Innovation. Dr. Vasan has no conflicts of interest. Mr. Agbafe is a fellow at Stanford Brainstorm and a first-year medical student at the University of Michigan, Ann Arbor. He has no conflicts of interest. Ms. Li is a policy intern at Stanford Brainstorm and an undergraduate student in the department of economics at the University of California, Berkeley. She has no conflicts of interest.

The COVID-19 pandemic is one of the most pressing public health challenges the United States has ever faced, and the resulting financial ruin and social isolation are creating a mental health pandemic that will continue well after COVID-19 lockdowns end. This mental health fallout may surpass the destruction from the virus with regard to disease, death, and distress. To understand which presidential candidate would best lead the mental health recovery, we identified three of the most critical issues in mental health and compared the plans of the two candidates.

Fighting the opioid epidemic

Over the last several years, the opioid epidemic has devastated American families and communities. Prior to the pandemic, drug overdoses were the leading cause of death for American adults under 50 years of age. The effects of COVID-19–enabled overdose deaths to rise even higher. Multiple elements of the pandemic – isolation, unemployment, and increased anxiety and depression – make those struggling with substance use even more vulnerable, and immediate and comprehensive action is needed to address this national tragedy.

Donald J. Trump: President Trump has been vocal and active in addressing this problem since he took office. One of the Trump administration’s successes is launching the Opioid and Drug Abuse Commission and rolling out a five-point strategy built around improving services, data, research, overdose-reversing drugs, and pain management. Last year, the Trump administration funded $10 billion over 5 years to combat both the opioid epidemic and mental health issues by building upon the 21st Century CURES Act. However, in this same budget, the administration proposed cutting funding by $600 million for SAMHSA, the Substance Abuse and Mental Health Services Administration, which is the top government agency for addressing and providing care for substance use.

President Trump also created an assistant secretary for mental health and substance use position in the Department of Health & Human Services, and appointed Elinore F. McCance-Katz, MD, PhD, a psychiatrist with a strong track record on fighting opioid abuse in Rhode Island, to the post.
 

Joe Biden: Former Vice President Biden emphasizes that substance use is “a disease of the brain,” refuting the long-held misconception that addiction is an issue of willpower. This stigmatization is very personal given that his own son Hunter reportedly suffered through mental health and substance use issues since his teenage years. However, Biden also had a major role in pushing forward the federal “war on drugs,” including his role in crafting the “Len Bias law.”

Mr. Biden has since released a multifaceted plan for reducing substance use, aiming to make prevention and treatment services more available through a $125 billion federal investment. There are also measures to hold pharmaceutical companies accountable for triggering the crisis, stop the flow of fentanyl to the United States, and restrict incentive payments from manufacturers to doctors so as to limit the dosing and usage of powerful opioids.
 

Accessing health care

One of the main dividing lines in this election has been the battle to either gut or build upon the Affordable Care Act (ACA). This will have deep ramifications on people’s access to health mental health services. Since COVID-19 started, more than 50% of Americans have reported worsening mental health. This makes it crucial that each candidate’s mental health plan is judged by how they would expand access to insurance, address unenforced parity laws, and protect those who have a mental health disorder as a preexisting condition.

Mr. Trump: Following a failed Senate vote to repeal this law, the Trump administration took a piecemeal approach to dismantling the ACA that included removing the individual mandate, enabling states to introduce Medicaid work requirements, and reducing cost-sharing subsidies to insurers.

If a re-elected Trump administration pursued a complete repeal of the ACA law, many individuals with previous access to mental health and substance abuse treatment via Medicaid expansion may lose access altogether. In addition, key mechanisms aimed at making sure that mental health services are covered by private health plans may be lost, which could undermine policies to address opioids and suicide. On the other hand, the Trump administration’s move during the pandemic to expand telemedicine services has also expanded access to mental health services.

Mr. Biden: Mr. Biden’s plan would build upon the ACA by working to achieve parity between the treatment of mental health and physical health. The ACA itself strengthened the Mental Health Parity and Addiction Equity Act (federal parity law), which Mr. Biden championed as vice president, by mandating that all private insurance cover mental health and substance abuse treatment. This act still exempts some health plans, such as larger employers; and many insurers have used loopholes in the policy to illegally deny what could be life-saving coverage.

It follows that those who can afford Mr. Biden’s proposed public option Medicare buy-in would receive more comprehensive mental health benefits. He also says he would invest in school and college mental health professionals, an important opportunity for early intervention given 75% of lifetime mental illness starts by age 24 years. While Mr. Biden has not stated a specific plan for addressing minority groups, whose mental health has been disproportionately affected by COVID-19, he has acknowledged that this unmet need should be targeted.
 

Addressing suicide

More than 3,000 Americans attempt suicide every day. Suicide is the second leading cause of death for America’s youth and one of the top 10 leading causes of death across the population. Numerous strategies are necessary to address suicide, but one of the most decisive is gun control. Gun violence is inextricably tied to suicide: States where gun prevalence is higher see about four times the number of suicides because of guns, whereas nonfirearm suicide rates are the same as those seen elsewhere. In 2017, of the nearly 40,000 people who died of gun violence, 60% were attributable to suicides. Since the pandemic started, there have been increases in reported suicidal thoughts and a nearly 1,000% increase in use of the national crisis hotline. This is especially concerning given the uptick during the pandemic of gun purchases; as of September, more guns have been purchased this year than any year before.

Mr. Trump: Prior to coronavirus, the Trump administration was unwilling to enact gun control legislation. In early 2017, Mr. Trump removed an Obama-era bill that would have expanded the background check database. It would have added those deemed legally unfit to handle their own funds and those who received Social Security funds for mental health reasons. During the lockdown, the administration made an advisory ruling declaring gun shops as essential businesses that states should keep open.

Mr. Biden: The former vice president has a history of supporting gun control measures in his time as a senator and vice president. In the Senate, Mr. Biden supported both the Brady handgun bill in 1993 and a ban on assault weapons in 1994. As vice president, he was tasked by President Obama to push for a renewed assault weapons ban and a background check bill (Manchin-Toomey bill).

During his 2020 presidential campaign, Mr. Biden has suggested creating universal background checks and reinstating bans on assault rifle sales. He has said that he is also open to having a federal buyback program for assault rifles from gun owners.
 

Why this matters

The winner of the 2020 election will lead an electorate that is reeling from the health, economic, and social consequences COVID-19. The next administration needs to act swiftly to address the mental health pandemic and have a keen awareness of what is ahead. As Americans make their voting decision, consider who has the best plans not only to contain the virus but also the mental health crises that are ravaging our nation.

Dr. Vasan is a clinical assistant professor of psychiatry at Stanford (Calif.) University, where she is founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation. She also serves as chief medical officer of Real, and chair of the American Psychiatric Association Committee on Innovation. Dr. Vasan has no conflicts of interest. Mr. Agbafe is a fellow at Stanford Brainstorm and a first-year medical student at the University of Michigan, Ann Arbor. He has no conflicts of interest. Ms. Li is a policy intern at Stanford Brainstorm and an undergraduate student in the department of economics at the University of California, Berkeley. She has no conflicts of interest.

The COVID-19 pandemic is one of the most pressing public health challenges the United States has ever faced, and the resulting financial ruin and social isolation are creating a mental health pandemic that will continue well after COVID-19 lockdowns end. This mental health fallout may surpass the destruction from the virus with regard to disease, death, and distress. To understand which presidential candidate would best lead the mental health recovery, we identified three of the most critical issues in mental health and compared the plans of the two candidates.

Fighting the opioid epidemic

Over the last several years, the opioid epidemic has devastated American families and communities. Prior to the pandemic, drug overdoses were the leading cause of death for American adults under 50 years of age. The effects of COVID-19–enabled overdose deaths to rise even higher. Multiple elements of the pandemic – isolation, unemployment, and increased anxiety and depression – make those struggling with substance use even more vulnerable, and immediate and comprehensive action is needed to address this national tragedy.

Donald J. Trump: President Trump has been vocal and active in addressing this problem since he took office. One of the Trump administration’s successes is launching the Opioid and Drug Abuse Commission and rolling out a five-point strategy built around improving services, data, research, overdose-reversing drugs, and pain management. Last year, the Trump administration funded $10 billion over 5 years to combat both the opioid epidemic and mental health issues by building upon the 21st Century CURES Act. However, in this same budget, the administration proposed cutting funding by $600 million for SAMHSA, the Substance Abuse and Mental Health Services Administration, which is the top government agency for addressing and providing care for substance use.

President Trump also created an assistant secretary for mental health and substance use position in the Department of Health & Human Services, and appointed Elinore F. McCance-Katz, MD, PhD, a psychiatrist with a strong track record on fighting opioid abuse in Rhode Island, to the post.
 

Joe Biden: Former Vice President Biden emphasizes that substance use is “a disease of the brain,” refuting the long-held misconception that addiction is an issue of willpower. This stigmatization is very personal given that his own son Hunter reportedly suffered through mental health and substance use issues since his teenage years. However, Biden also had a major role in pushing forward the federal “war on drugs,” including his role in crafting the “Len Bias law.”

Mr. Biden has since released a multifaceted plan for reducing substance use, aiming to make prevention and treatment services more available through a $125 billion federal investment. There are also measures to hold pharmaceutical companies accountable for triggering the crisis, stop the flow of fentanyl to the United States, and restrict incentive payments from manufacturers to doctors so as to limit the dosing and usage of powerful opioids.
 

Accessing health care

One of the main dividing lines in this election has been the battle to either gut or build upon the Affordable Care Act (ACA). This will have deep ramifications on people’s access to health mental health services. Since COVID-19 started, more than 50% of Americans have reported worsening mental health. This makes it crucial that each candidate’s mental health plan is judged by how they would expand access to insurance, address unenforced parity laws, and protect those who have a mental health disorder as a preexisting condition.

Mr. Trump: Following a failed Senate vote to repeal this law, the Trump administration took a piecemeal approach to dismantling the ACA that included removing the individual mandate, enabling states to introduce Medicaid work requirements, and reducing cost-sharing subsidies to insurers.

If a re-elected Trump administration pursued a complete repeal of the ACA law, many individuals with previous access to mental health and substance abuse treatment via Medicaid expansion may lose access altogether. In addition, key mechanisms aimed at making sure that mental health services are covered by private health plans may be lost, which could undermine policies to address opioids and suicide. On the other hand, the Trump administration’s move during the pandemic to expand telemedicine services has also expanded access to mental health services.

Mr. Biden: Mr. Biden’s plan would build upon the ACA by working to achieve parity between the treatment of mental health and physical health. The ACA itself strengthened the Mental Health Parity and Addiction Equity Act (federal parity law), which Mr. Biden championed as vice president, by mandating that all private insurance cover mental health and substance abuse treatment. This act still exempts some health plans, such as larger employers; and many insurers have used loopholes in the policy to illegally deny what could be life-saving coverage.

It follows that those who can afford Mr. Biden’s proposed public option Medicare buy-in would receive more comprehensive mental health benefits. He also says he would invest in school and college mental health professionals, an important opportunity for early intervention given 75% of lifetime mental illness starts by age 24 years. While Mr. Biden has not stated a specific plan for addressing minority groups, whose mental health has been disproportionately affected by COVID-19, he has acknowledged that this unmet need should be targeted.
 

Addressing suicide

More than 3,000 Americans attempt suicide every day. Suicide is the second leading cause of death for America’s youth and one of the top 10 leading causes of death across the population. Numerous strategies are necessary to address suicide, but one of the most decisive is gun control. Gun violence is inextricably tied to suicide: States where gun prevalence is higher see about four times the number of suicides because of guns, whereas nonfirearm suicide rates are the same as those seen elsewhere. In 2017, of the nearly 40,000 people who died of gun violence, 60% were attributable to suicides. Since the pandemic started, there have been increases in reported suicidal thoughts and a nearly 1,000% increase in use of the national crisis hotline. This is especially concerning given the uptick during the pandemic of gun purchases; as of September, more guns have been purchased this year than any year before.

Mr. Trump: Prior to coronavirus, the Trump administration was unwilling to enact gun control legislation. In early 2017, Mr. Trump removed an Obama-era bill that would have expanded the background check database. It would have added those deemed legally unfit to handle their own funds and those who received Social Security funds for mental health reasons. During the lockdown, the administration made an advisory ruling declaring gun shops as essential businesses that states should keep open.

Mr. Biden: The former vice president has a history of supporting gun control measures in his time as a senator and vice president. In the Senate, Mr. Biden supported both the Brady handgun bill in 1993 and a ban on assault weapons in 1994. As vice president, he was tasked by President Obama to push for a renewed assault weapons ban and a background check bill (Manchin-Toomey bill).

During his 2020 presidential campaign, Mr. Biden has suggested creating universal background checks and reinstating bans on assault rifle sales. He has said that he is also open to having a federal buyback program for assault rifles from gun owners.
 

Why this matters

The winner of the 2020 election will lead an electorate that is reeling from the health, economic, and social consequences COVID-19. The next administration needs to act swiftly to address the mental health pandemic and have a keen awareness of what is ahead. As Americans make their voting decision, consider who has the best plans not only to contain the virus but also the mental health crises that are ravaging our nation.

Dr. Vasan is a clinical assistant professor of psychiatry at Stanford (Calif.) University, where she is founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation. She also serves as chief medical officer of Real, and chair of the American Psychiatric Association Committee on Innovation. Dr. Vasan has no conflicts of interest. Mr. Agbafe is a fellow at Stanford Brainstorm and a first-year medical student at the University of Michigan, Ann Arbor. He has no conflicts of interest. Ms. Li is a policy intern at Stanford Brainstorm and an undergraduate student in the department of economics at the University of California, Berkeley. She has no conflicts of interest.

After years of dormancy, psychiatric drug development is showing signs of life. There is the novel antipsychotic lumateperone, recently approved for adults with schizophrenia. Brexanolone was approved last year for postpartum depression. And perhaps generating the most attention lately among psychiatrists – and people with depression – is the use of ketamine and esketamine for depression.

Columbia psychiatrist J. John Mann, MD, a professor of translational neuroscience and a mood disorder specialist, has been involved in several notable studies of ketamine in patients with depression. He and his colleagues’ recent research efforts include a randomized study into ketamine’s ability to reduce suicidal thoughts in bipolar depression and an MRI analysis illuminating the role that dosing plays in antidepressant effects.

Dr. Mann sat down with his Columbia colleague Lloyd I. Sederer, MD, to discuss how, nearly a year after its approval, ketamine fits into mental health care.
 

Dr. Sederer: Nearly 20 million people in this country alone suffer from clinical depression every year. That means they have a functional impairment in addition to their suffering and are at risk of taking their own lives. Depression is a very prevalent, painful, and disabling condition. The psychopharmacologic treatments we’ve had have been more or less the same for the past 20 or 30 years.

We’ve asked Dr. Mann to … talk to us about ketamine and its nasal preparation esketamine, which is a novel psychopharmacologic treatment. Dr. Mann, please tell us about ketamine, its utility, and the yet-to-be-answered questions.

Dr. Mann: Ketamine and esketamine, which is a component of ketamine itself, is different from traditional antidepressant medications in three fundamental ways.

The first is that it acts very quickly. Traditional antidepressants take 4, 6, 8 weeks to work. This means that the patient has to put up with a great deal of suffering while waiting for a response. And the probability of the medication working isn’t that high. About 50%-70% of individuals will respond eventually at the end of this ride. But ketamine, when it works, does so in 2 hours. That’s a totally different timescale.

The second aspect is that, when it does work, it often works very robustly, even though it’s a quick-acting antidepressant. The patient often quickly feels distinctly better.

Very often when you’re using traditional antidepressants, it takes a while for the improvement to reach the point that the patient is confident that they are clearly better, and too often that does not happen.

Dr. Sederer: As the treating doctor, you’re trying to keep that patient’s hope alive, even though we don’t have substantial evidence that they’re going to respond.

Dr. Mann: Exactly. One of the difficulties of keeping patients on track with traditional antidepressants is that, after the first dose or two, they have all the side effects and yet no benefit has emerged. In many ways patients sometimes feel that they’re going backwards. They have all of their depression plus the side effects of the medication.

But with ketamine, it’s rather different. You come in, you have the treatment, and many patients feel improved in a couple of hours. And not just a bit improved, but in many cases distinctly improved.

It’s very important for clinicians to appreciate that ketamine will work in patients who have a classically described treatment-resistant depression, meaning they’ve tried several other types of antidepressant medications that haven’t worked.

A prerequisite for treatment with ketamine is that they have had a number of treatment failures. The labeling for the intranasal esketamine states that you should try the other antidepressants first and then use this if they don’t work. The fact that ketamine can work even when the other medications have failed is a huge advantage.

Dr. Sederer: There is another feature of ketamine, in that it also has a pronounced benefit for suicidal ideation, which your research has reported on.

Dr. Mann: Yes, we’ve learned over the years that depression and suicidality are in some ways comorbid conditions. That both have to be addressed in order to keep somebody alive so that they can respond to treatment.

That’s a very important point. If the patient is suffering from depression and the antidepressant takes weeks to work, they may lose hope during that time. They may become overwhelmed by the suicidal ideation, no longer able to control or resist the impulse to take their life. A lot of the management is therefore to try to help support the patient (and family) so that these thoughts never become too compelling. Often we have to consider hospitalization to protect these patients so that they can stay alive long enough for the antidepressant to work. But ketamine not only has this very rapid effect for their depression, it also has a partly independent effect on suicidal ideation that is equally rapid and robust, which can render the patient safer.

Dr. Sederer: In other words, it’s effective and rapidly so for depression, with a bonus of reducing suicidality? This sounds almost too good to be true.

Dr. Mann: There are some limitations that we have to keep in mind. One limitation is that a single administration of ketamine will produce this robust improvement but it will only persist for most people for 5-7 days.

Dr. Sederer: Is the same duration true for scheduling the next treatment as well?

Dr. Mann: Yes, it is. The patient will gradually begin to deteriorate if you do not repeat the treatment. But as we showed in our randomized controlled clinical study, with ketamine for suicidal ideation, if you continue to deliver the medication, you can sustain the benefit.

Dr. Sederer: Can a person receive both ketamine and a conventional antidepressant at the same time?

Dr. Mann: Yes. In this study, half of the patients were actually continued on their previous medication while we added the ketamine on top of that. It worked very well.

In practice, people use two approaches. One approach used by most ketamine clinics is to give six doses of ketamine at a frequency of about two per week. Then they will reduce the frequency down to once a week for a few more doses and then once a month.

Dr. Sederer:: And this is a ketamine infusion?

Dr. Mann: Yes, this generally has been a ketamine infusion. This approach seems to work quite well. But that may not be necessary.

Another strategy is to give one, two, or three doses of ketamine. If the patient doesn’t respond robustly to two or three doses, they’re not going to respond to subsequent doses.

Dr. Sederer: So, initial responses are a predictor of future response?

Dr. Mann: Exactly. Now, if they haven’t done well with two or three doses, then you’ve got to use other treatments. But if they do well with the two or three, then you’ve got a choice: You can either complete the treatment course with ketamine and then continue them on antidepressant medications, or simply treat them with ketamine alone. What we tend to do is to treat with only antidepressant medications after a small number of ketamine treatments. We also use ketamine as a kind of “rescue medication” if they relapse into severe depression, though this is true for only a minority of patients.

Dr. Sederer: One of the things that we’ve learned is that antidepressants have a very beneficial effect for some people, but then they wear out and the person starts to relapse. Should ketamine be studied as an intervention for people who are no longer responding to the antidepressant(s) that they are on?

Dr. Mann: We do not really know the answer to that question. My experience treating very seriously ill patients is that sometimes the ketamine will work very well the first time or the second time but then in the future, if you try to use it as a rescue medication, it might not work that well. There is some clinical experience that suggests that that may be true for some people. But we have no idea about the frequency or timing with which this might happen. That’s all uncertain.

Moreover, most of our control clinical trial data come from either one dose of ketamine or from a few trials where people have received multiple doses of ketamine, followed by a bit of a taper. But there are very, very few of those types of studies. We’re still learning about the use of this medication.

Dr. Sederer: Importantly, you referenced the side effects of antidepressants. What are the side effects and risks of ketamine?

Dr. Mann: We know a lot more about the immediate short-term side effects of a single dose or a few doses of ketamine. Most people will get a kind of tripping experience. They’ll feel a bit unreal, or their circumstances or experiences of the world feel a bit distorted.

Some patients develop strange ideas. Most patients don’t enjoy those symptoms, even though I know ketamine is used as a party drug, and so on and so forth.

Dr. Sederer: It seems that the context is what matters.

Dr. Mann: Yes. And in a clinic context, most patients simply don’t enjoy these types of dissociative experiences, but they put up with them. They’re not severe, in general.

Dr. Sederer: Is part of the preparation of the patient telling them that this may happen?

Dr. Mann: Yes. We try to explain the potential for these symptoms and that most people get them. These side effects almost invariably terminate with the cessation of the administration.

Dr. Sederer: What’s the typical duration of the infusion you use?

Dr. Mann: Traditionally, infusion is 40 minutes and always in a clinic setting.

Dr. Sederer: And that’s because of the concern that a patient may have these symptoms?

Dr. Mann: Exactly. They may have dissociative effects that they’re disturbed by, and we need to monitor that. They’re probably going to remain under observation in the clinic for about the same amount of time because it takes about the same time for these effects to wear off.

The other consideration is that some people get a little nausea. In our experience with the intravenous ketamine, there’s also a problematic side effect that their blood pressure will be slightly raised. Therefore, it’s good to know that the person’s blood pressure is under control before they begin the treatments and that you’re monitoring it during administration.

Dr. Sederer: What are the differences you’re discovering between esketamine and ketamine?

Dr. Mann: It is a bit different. We’ve just completed a very important National Institutes of Health–funded clinical trial here at Columbia showing that with esketamine or ketamine itself, the dose and the blood levels are very closely related to the robustness of the clinical response.

When you give a drug intravenously, you give a very reliable dose. When you give the drug over 40 minutes, you’re spreading the dose administration over a period of time so that it doesn’t peak very high. The side effects appear to be proportional to the peak dose.

When you give it intranasally, you give the drug over a much shorter period of time. Even if you use more than one intranasal administration to give the whole dose, it’s still a relatively shorter time, compared with the 40 minutes.

Dr. Sederer: This means that to get the equivalent dose intranasally, the patient is going to have to experience a higher peak. Can you predict that those patients who are treated intranasally are going to have more side effects?

Dr. Mann: Right. And that should be explained to the patient. You will not need an intravenous line inserted, which some people might find highly appealing and advantageous, but you will probably have more side effects.

Also, in general, intranasal absorption of drugs is more variable. The predictability of the blood level and, therefore, the degree of antidepressant effect is not as good intranasally as intravenously.

Now, all of this is anecdotal clinical experience, based on theoretical pharmacology, because nobody has actually done a head-to-head control comparison.

Dr. Sederer: What about the cost of both of these preparations?

Dr. Mann: There is a bit of a range in pricing between ketamine clinics around the country. It’s always important to find out what they charge per administration. And then it makes a difference whether you have two or three administrations versus six plus further tapered administration. Clearly, the cost can vary a great deal.

Dr. Sederer: But it’s generally not covered by insurance, so most people are paying out of pocket.

Dr. Mann: Yes. The intranasal ketamine is still in negotiation at the moment, but it should be resolved before it’s fully marketed.

Dr. Sederer: Ketamine is used for major depression. Does it have utility in bipolar depression?

Dr. Mann: We and some others have done initial studies in bipolar depression. In our view, it’s probably going to be as effective in bipolar disorder as it is in major depressive disorder, unipolar depression.

We haven’t seen any manic episodes triggered, but we don’t give repeated doses. We allow research patients to stay on anticonvulsants or mood stabilizers, so that’s helpful. Generally, people with bipolar disorder who come for ketamine treatment for their depression are coming on a mood stabilizer, because that and perhaps other conventional antidepressants have not proven to be effective. So, I think that ketamine plus mood stabilizers seems to be very promising.

Dr. Sederer: I want to return to the antisuicidal properties that you had previously mentioned. I heard from a colleague about a patient who had been admitted to a psychiatric inpatient unit. The patient was in her 20s; she did not have major depression but was persistently suicidal, constantly trying to hurt herself in any way she could. But that seemed to be more a product of borderline personality disorder, with its impulsive and self-destructive problems.

In the end, they tried intranasal ketamine. The response was, just as you described, robust. Her self-injurious behavior dropped in a very pronounced way within a day or two. But she then did require administrations a couple of times a week in order to keep that suicidality at bay.

Based on that example, I’m wondering whether there is an application here for people who are suicidal yet who may not have features of major depression or bipolar depression.

Dr. Mann: It’s a very interesting suggestion for which we have no data-based answer. However, we have a clue from the study that we published in the American Journal of Psychiatry and have since published further analyses on.

The reasons that people die by suicide, or make suicide attempts, are not entirely attributable to the fact that they suffer from a mood disorder.

Dr. Sederer: Yes, because only a minority of individuals with a mood disorder ever make suicide attempts. But there is a subgroup at risk.

Dr. Mann: Here at Columbia, we’ve promulgated the stress-diathesis model for suicidal behavior. A stressor could be external life events, but the internal stressor would be something like an acute episode of depression.

But predisposition also plays an important role, which has several elements to it. One is decision-making. These are patients with a propensity to go for a short-term, quick relief. In other words, a patient would be seeking immediate relief rather than waiting for the delayed improvement from an antidepressant. They’re more prone to act on the pain of the depression and terminate their lives – to try to end their pain – rather than wait and hope that, in time, there’s a chance that the antidepressant will work.

Dr. Sederer: What else do you want to share with our viewers about this medication and how it’s used?

Dr. Mann: My goal in treating patients is to try to use the least amount of medication possible. We do not really know yet the long-term safety of ketamine treatment.

It’s been used for many decades in anesthesia, but people don’t get repeated anesthetic doses of ketamine. And higher doses of ketamine given repeatedly have been shown in preclinical studies to produce little lesions in the brain, which is not good. But we’re using much lower doses.

As we potentially move into a time when we could be giving multiple doses of ketamine to patients, we should remember that we need to be cautious about that. If we don’t need to give them more doses, we shouldn’t. We should know that there is a potential downside that we don’t fully understand yet to giving ketamine repeatedly.

And that’s aside from its abuse potential. We know that people have employed ketamine for physical and emotional pain, and when they administer it themselves, they tend to get dependent on it. In a clinic setting it’s given in a very formal and structured fashion, a bit like the administration of opioids. In that setting, it is much safer and the risk for abuse and diversion is minimized. But we need to remember that this drug does have abuse potential and perhaps not yet fully measurable neurotoxic effects.

Dr. Sederer: If physicians, nurses, and other professional clinicians want to learn more about this medication, what are the accurate, reliable sources of information to which you suggest they turn?

Dr. Mann: The National Institute of Mental Health’s website offers good and reliable information for patients and their families. It is an unbiased, scientific, and thoughtful source of information, and better than just trolling the Internet for information.

People are much more sophisticated now than they were 20 years ago in these matters, and scientific papers are much more accessible to the public. Reading papers in recognized journals is also a useful way to gain information.

For example, one of the major papers that we published in the American Journal of Psychiatry is available to anybody on the Internet to read. So, I encourage people to make their own inquiries and talk to more than one doctor. Informed patients and families are the best partners a doctor can ever have. We encourage that in all of our patients.

Dr. Sederer: I want to thank you very much, Dr. Mann, for your work in this area and for joining us here at Medscape and Columbia Psychiatry to teach us so much about what is truly a novel psychopharmacologic agent, yet one where we still have a lot more to learn.

A version of this article originally appeared on Medscape.com.

After years of dormancy, psychiatric drug development is showing signs of life. There is the novel antipsychotic lumateperone, recently approved for adults with schizophrenia. Brexanolone was approved last year for postpartum depression. And perhaps generating the most attention lately among psychiatrists – and people with depression – is the use of ketamine and esketamine for depression.

Columbia psychiatrist J. John Mann, MD, a professor of translational neuroscience and a mood disorder specialist, has been involved in several notable studies of ketamine in patients with depression. He and his colleagues’ recent research efforts include a randomized study into ketamine’s ability to reduce suicidal thoughts in bipolar depression and an MRI analysis illuminating the role that dosing plays in antidepressant effects.

Dr. Mann sat down with his Columbia colleague Lloyd I. Sederer, MD, to discuss how, nearly a year after its approval, ketamine fits into mental health care.
 

Dr. Sederer: Nearly 20 million people in this country alone suffer from clinical depression every year. That means they have a functional impairment in addition to their suffering and are at risk of taking their own lives. Depression is a very prevalent, painful, and disabling condition. The psychopharmacologic treatments we’ve had have been more or less the same for the past 20 or 30 years.

We’ve asked Dr. Mann to … talk to us about ketamine and its nasal preparation esketamine, which is a novel psychopharmacologic treatment. Dr. Mann, please tell us about ketamine, its utility, and the yet-to-be-answered questions.

Dr. Mann: Ketamine and esketamine, which is a component of ketamine itself, is different from traditional antidepressant medications in three fundamental ways.

The first is that it acts very quickly. Traditional antidepressants take 4, 6, 8 weeks to work. This means that the patient has to put up with a great deal of suffering while waiting for a response. And the probability of the medication working isn’t that high. About 50%-70% of individuals will respond eventually at the end of this ride. But ketamine, when it works, does so in 2 hours. That’s a totally different timescale.

The second aspect is that, when it does work, it often works very robustly, even though it’s a quick-acting antidepressant. The patient often quickly feels distinctly better.

Very often when you’re using traditional antidepressants, it takes a while for the improvement to reach the point that the patient is confident that they are clearly better, and too often that does not happen.

Dr. Sederer: As the treating doctor, you’re trying to keep that patient’s hope alive, even though we don’t have substantial evidence that they’re going to respond.

Dr. Mann: Exactly. One of the difficulties of keeping patients on track with traditional antidepressants is that, after the first dose or two, they have all the side effects and yet no benefit has emerged. In many ways patients sometimes feel that they’re going backwards. They have all of their depression plus the side effects of the medication.

But with ketamine, it’s rather different. You come in, you have the treatment, and many patients feel improved in a couple of hours. And not just a bit improved, but in many cases distinctly improved.

It’s very important for clinicians to appreciate that ketamine will work in patients who have a classically described treatment-resistant depression, meaning they’ve tried several other types of antidepressant medications that haven’t worked.

A prerequisite for treatment with ketamine is that they have had a number of treatment failures. The labeling for the intranasal esketamine states that you should try the other antidepressants first and then use this if they don’t work. The fact that ketamine can work even when the other medications have failed is a huge advantage.

Dr. Sederer: There is another feature of ketamine, in that it also has a pronounced benefit for suicidal ideation, which your research has reported on.

Dr. Mann: Yes, we’ve learned over the years that depression and suicidality are in some ways comorbid conditions. That both have to be addressed in order to keep somebody alive so that they can respond to treatment.

That’s a very important point. If the patient is suffering from depression and the antidepressant takes weeks to work, they may lose hope during that time. They may become overwhelmed by the suicidal ideation, no longer able to control or resist the impulse to take their life. A lot of the management is therefore to try to help support the patient (and family) so that these thoughts never become too compelling. Often we have to consider hospitalization to protect these patients so that they can stay alive long enough for the antidepressant to work. But ketamine not only has this very rapid effect for their depression, it also has a partly independent effect on suicidal ideation that is equally rapid and robust, which can render the patient safer.

Dr. Sederer: In other words, it’s effective and rapidly so for depression, with a bonus of reducing suicidality? This sounds almost too good to be true.

Dr. Mann: There are some limitations that we have to keep in mind. One limitation is that a single administration of ketamine will produce this robust improvement but it will only persist for most people for 5-7 days.

Dr. Sederer: Is the same duration true for scheduling the next treatment as well?

Dr. Mann: Yes, it is. The patient will gradually begin to deteriorate if you do not repeat the treatment. But as we showed in our randomized controlled clinical study, with ketamine for suicidal ideation, if you continue to deliver the medication, you can sustain the benefit.

Dr. Sederer: Can a person receive both ketamine and a conventional antidepressant at the same time?

Dr. Mann: Yes. In this study, half of the patients were actually continued on their previous medication while we added the ketamine on top of that. It worked very well.

In practice, people use two approaches. One approach used by most ketamine clinics is to give six doses of ketamine at a frequency of about two per week. Then they will reduce the frequency down to once a week for a few more doses and then once a month.

Dr. Sederer:: And this is a ketamine infusion?

Dr. Mann: Yes, this generally has been a ketamine infusion. This approach seems to work quite well. But that may not be necessary.

Another strategy is to give one, two, or three doses of ketamine. If the patient doesn’t respond robustly to two or three doses, they’re not going to respond to subsequent doses.

Dr. Sederer: So, initial responses are a predictor of future response?

Dr. Mann: Exactly. Now, if they haven’t done well with two or three doses, then you’ve got to use other treatments. But if they do well with the two or three, then you’ve got a choice: You can either complete the treatment course with ketamine and then continue them on antidepressant medications, or simply treat them with ketamine alone. What we tend to do is to treat with only antidepressant medications after a small number of ketamine treatments. We also use ketamine as a kind of “rescue medication” if they relapse into severe depression, though this is true for only a minority of patients.

Dr. Sederer: One of the things that we’ve learned is that antidepressants have a very beneficial effect for some people, but then they wear out and the person starts to relapse. Should ketamine be studied as an intervention for people who are no longer responding to the antidepressant(s) that they are on?

Dr. Mann: We do not really know the answer to that question. My experience treating very seriously ill patients is that sometimes the ketamine will work very well the first time or the second time but then in the future, if you try to use it as a rescue medication, it might not work that well. There is some clinical experience that suggests that that may be true for some people. But we have no idea about the frequency or timing with which this might happen. That’s all uncertain.

Moreover, most of our control clinical trial data come from either one dose of ketamine or from a few trials where people have received multiple doses of ketamine, followed by a bit of a taper. But there are very, very few of those types of studies. We’re still learning about the use of this medication.

Dr. Sederer: Importantly, you referenced the side effects of antidepressants. What are the side effects and risks of ketamine?

Dr. Mann: We know a lot more about the immediate short-term side effects of a single dose or a few doses of ketamine. Most people will get a kind of tripping experience. They’ll feel a bit unreal, or their circumstances or experiences of the world feel a bit distorted.

Some patients develop strange ideas. Most patients don’t enjoy those symptoms, even though I know ketamine is used as a party drug, and so on and so forth.

Dr. Sederer: It seems that the context is what matters.

Dr. Mann: Yes. And in a clinic context, most patients simply don’t enjoy these types of dissociative experiences, but they put up with them. They’re not severe, in general.

Dr. Sederer: Is part of the preparation of the patient telling them that this may happen?

Dr. Mann: Yes. We try to explain the potential for these symptoms and that most people get them. These side effects almost invariably terminate with the cessation of the administration.

Dr. Sederer: What’s the typical duration of the infusion you use?

Dr. Mann: Traditionally, infusion is 40 minutes and always in a clinic setting.

Dr. Sederer: And that’s because of the concern that a patient may have these symptoms?

Dr. Mann: Exactly. They may have dissociative effects that they’re disturbed by, and we need to monitor that. They’re probably going to remain under observation in the clinic for about the same amount of time because it takes about the same time for these effects to wear off.

The other consideration is that some people get a little nausea. In our experience with the intravenous ketamine, there’s also a problematic side effect that their blood pressure will be slightly raised. Therefore, it’s good to know that the person’s blood pressure is under control before they begin the treatments and that you’re monitoring it during administration.

Dr. Sederer: What are the differences you’re discovering between esketamine and ketamine?

Dr. Mann: It is a bit different. We’ve just completed a very important National Institutes of Health–funded clinical trial here at Columbia showing that with esketamine or ketamine itself, the dose and the blood levels are very closely related to the robustness of the clinical response.

When you give a drug intravenously, you give a very reliable dose. When you give the drug over 40 minutes, you’re spreading the dose administration over a period of time so that it doesn’t peak very high. The side effects appear to be proportional to the peak dose.

When you give it intranasally, you give the drug over a much shorter period of time. Even if you use more than one intranasal administration to give the whole dose, it’s still a relatively shorter time, compared with the 40 minutes.

Dr. Sederer: This means that to get the equivalent dose intranasally, the patient is going to have to experience a higher peak. Can you predict that those patients who are treated intranasally are going to have more side effects?

Dr. Mann: Right. And that should be explained to the patient. You will not need an intravenous line inserted, which some people might find highly appealing and advantageous, but you will probably have more side effects.

Also, in general, intranasal absorption of drugs is more variable. The predictability of the blood level and, therefore, the degree of antidepressant effect is not as good intranasally as intravenously.

Now, all of this is anecdotal clinical experience, based on theoretical pharmacology, because nobody has actually done a head-to-head control comparison.

Dr. Sederer: What about the cost of both of these preparations?

Dr. Mann: There is a bit of a range in pricing between ketamine clinics around the country. It’s always important to find out what they charge per administration. And then it makes a difference whether you have two or three administrations versus six plus further tapered administration. Clearly, the cost can vary a great deal.

Dr. Sederer: But it’s generally not covered by insurance, so most people are paying out of pocket.

Dr. Mann: Yes. The intranasal ketamine is still in negotiation at the moment, but it should be resolved before it’s fully marketed.

Dr. Sederer: Ketamine is used for major depression. Does it have utility in bipolar depression?

Dr. Mann: We and some others have done initial studies in bipolar depression. In our view, it’s probably going to be as effective in bipolar disorder as it is in major depressive disorder, unipolar depression.

We haven’t seen any manic episodes triggered, but we don’t give repeated doses. We allow research patients to stay on anticonvulsants or mood stabilizers, so that’s helpful. Generally, people with bipolar disorder who come for ketamine treatment for their depression are coming on a mood stabilizer, because that and perhaps other conventional antidepressants have not proven to be effective. So, I think that ketamine plus mood stabilizers seems to be very promising.

Dr. Sederer: I want to return to the antisuicidal properties that you had previously mentioned. I heard from a colleague about a patient who had been admitted to a psychiatric inpatient unit. The patient was in her 20s; she did not have major depression but was persistently suicidal, constantly trying to hurt herself in any way she could. But that seemed to be more a product of borderline personality disorder, with its impulsive and self-destructive problems.

In the end, they tried intranasal ketamine. The response was, just as you described, robust. Her self-injurious behavior dropped in a very pronounced way within a day or two. But she then did require administrations a couple of times a week in order to keep that suicidality at bay.

Based on that example, I’m wondering whether there is an application here for people who are suicidal yet who may not have features of major depression or bipolar depression.

Dr. Mann: It’s a very interesting suggestion for which we have no data-based answer. However, we have a clue from the study that we published in the American Journal of Psychiatry and have since published further analyses on.

The reasons that people die by suicide, or make suicide attempts, are not entirely attributable to the fact that they suffer from a mood disorder.

Dr. Sederer: Yes, because only a minority of individuals with a mood disorder ever make suicide attempts. But there is a subgroup at risk.

Dr. Mann: Here at Columbia, we’ve promulgated the stress-diathesis model for suicidal behavior. A stressor could be external life events, but the internal stressor would be something like an acute episode of depression.

But predisposition also plays an important role, which has several elements to it. One is decision-making. These are patients with a propensity to go for a short-term, quick relief. In other words, a patient would be seeking immediate relief rather than waiting for the delayed improvement from an antidepressant. They’re more prone to act on the pain of the depression and terminate their lives – to try to end their pain – rather than wait and hope that, in time, there’s a chance that the antidepressant will work.

Dr. Sederer: What else do you want to share with our viewers about this medication and how it’s used?

Dr. Mann: My goal in treating patients is to try to use the least amount of medication possible. We do not really know yet the long-term safety of ketamine treatment.

It’s been used for many decades in anesthesia, but people don’t get repeated anesthetic doses of ketamine. And higher doses of ketamine given repeatedly have been shown in preclinical studies to produce little lesions in the brain, which is not good. But we’re using much lower doses.

As we potentially move into a time when we could be giving multiple doses of ketamine to patients, we should remember that we need to be cautious about that. If we don’t need to give them more doses, we shouldn’t. We should know that there is a potential downside that we don’t fully understand yet to giving ketamine repeatedly.

And that’s aside from its abuse potential. We know that people have employed ketamine for physical and emotional pain, and when they administer it themselves, they tend to get dependent on it. In a clinic setting it’s given in a very formal and structured fashion, a bit like the administration of opioids. In that setting, it is much safer and the risk for abuse and diversion is minimized. But we need to remember that this drug does have abuse potential and perhaps not yet fully measurable neurotoxic effects.

Dr. Sederer: If physicians, nurses, and other professional clinicians want to learn more about this medication, what are the accurate, reliable sources of information to which you suggest they turn?

Dr. Mann: The National Institute of Mental Health’s website offers good and reliable information for patients and their families. It is an unbiased, scientific, and thoughtful source of information, and better than just trolling the Internet for information.

People are much more sophisticated now than they were 20 years ago in these matters, and scientific papers are much more accessible to the public. Reading papers in recognized journals is also a useful way to gain information.

For example, one of the major papers that we published in the American Journal of Psychiatry is available to anybody on the Internet to read. So, I encourage people to make their own inquiries and talk to more than one doctor. Informed patients and families are the best partners a doctor can ever have. We encourage that in all of our patients.

Dr. Sederer: I want to thank you very much, Dr. Mann, for your work in this area and for joining us here at Medscape and Columbia Psychiatry to teach us so much about what is truly a novel psychopharmacologic agent, yet one where we still have a lot more to learn.

A version of this article originally appeared on Medscape.com.

After years of dormancy, psychiatric drug development is showing signs of life. There is the novel antipsychotic lumateperone, recently approved for adults with schizophrenia. Brexanolone was approved last year for postpartum depression. And perhaps generating the most attention lately among psychiatrists – and people with depression – is the use of ketamine and esketamine for depression.

Columbia psychiatrist J. John Mann, MD, a professor of translational neuroscience and a mood disorder specialist, has been involved in several notable studies of ketamine in patients with depression. He and his colleagues’ recent research efforts include a randomized study into ketamine’s ability to reduce suicidal thoughts in bipolar depression and an MRI analysis illuminating the role that dosing plays in antidepressant effects.

Dr. Mann sat down with his Columbia colleague Lloyd I. Sederer, MD, to discuss how, nearly a year after its approval, ketamine fits into mental health care.
 

Dr. Sederer: Nearly 20 million people in this country alone suffer from clinical depression every year. That means they have a functional impairment in addition to their suffering and are at risk of taking their own lives. Depression is a very prevalent, painful, and disabling condition. The psychopharmacologic treatments we’ve had have been more or less the same for the past 20 or 30 years.

We’ve asked Dr. Mann to … talk to us about ketamine and its nasal preparation esketamine, which is a novel psychopharmacologic treatment. Dr. Mann, please tell us about ketamine, its utility, and the yet-to-be-answered questions.

Dr. Mann: Ketamine and esketamine, which is a component of ketamine itself, is different from traditional antidepressant medications in three fundamental ways.

The first is that it acts very quickly. Traditional antidepressants take 4, 6, 8 weeks to work. This means that the patient has to put up with a great deal of suffering while waiting for a response. And the probability of the medication working isn’t that high. About 50%-70% of individuals will respond eventually at the end of this ride. But ketamine, when it works, does so in 2 hours. That’s a totally different timescale.

The second aspect is that, when it does work, it often works very robustly, even though it’s a quick-acting antidepressant. The patient often quickly feels distinctly better.

Very often when you’re using traditional antidepressants, it takes a while for the improvement to reach the point that the patient is confident that they are clearly better, and too often that does not happen.

Dr. Sederer: As the treating doctor, you’re trying to keep that patient’s hope alive, even though we don’t have substantial evidence that they’re going to respond.

Dr. Mann: Exactly. One of the difficulties of keeping patients on track with traditional antidepressants is that, after the first dose or two, they have all the side effects and yet no benefit has emerged. In many ways patients sometimes feel that they’re going backwards. They have all of their depression plus the side effects of the medication.

But with ketamine, it’s rather different. You come in, you have the treatment, and many patients feel improved in a couple of hours. And not just a bit improved, but in many cases distinctly improved.

It’s very important for clinicians to appreciate that ketamine will work in patients who have a classically described treatment-resistant depression, meaning they’ve tried several other types of antidepressant medications that haven’t worked.

A prerequisite for treatment with ketamine is that they have had a number of treatment failures. The labeling for the intranasal esketamine states that you should try the other antidepressants first and then use this if they don’t work. The fact that ketamine can work even when the other medications have failed is a huge advantage.

Dr. Sederer: There is another feature of ketamine, in that it also has a pronounced benefit for suicidal ideation, which your research has reported on.

Dr. Mann: Yes, we’ve learned over the years that depression and suicidality are in some ways comorbid conditions. That both have to be addressed in order to keep somebody alive so that they can respond to treatment.

That’s a very important point. If the patient is suffering from depression and the antidepressant takes weeks to work, they may lose hope during that time. They may become overwhelmed by the suicidal ideation, no longer able to control or resist the impulse to take their life. A lot of the management is therefore to try to help support the patient (and family) so that these thoughts never become too compelling. Often we have to consider hospitalization to protect these patients so that they can stay alive long enough for the antidepressant to work. But ketamine not only has this very rapid effect for their depression, it also has a partly independent effect on suicidal ideation that is equally rapid and robust, which can render the patient safer.

Dr. Sederer: In other words, it’s effective and rapidly so for depression, with a bonus of reducing suicidality? This sounds almost too good to be true.

Dr. Mann: There are some limitations that we have to keep in mind. One limitation is that a single administration of ketamine will produce this robust improvement but it will only persist for most people for 5-7 days.

Dr. Sederer: Is the same duration true for scheduling the next treatment as well?

Dr. Mann: Yes, it is. The patient will gradually begin to deteriorate if you do not repeat the treatment. But as we showed in our randomized controlled clinical study, with ketamine for suicidal ideation, if you continue to deliver the medication, you can sustain the benefit.

Dr. Sederer: Can a person receive both ketamine and a conventional antidepressant at the same time?

Dr. Mann: Yes. In this study, half of the patients were actually continued on their previous medication while we added the ketamine on top of that. It worked very well.

In practice, people use two approaches. One approach used by most ketamine clinics is to give six doses of ketamine at a frequency of about two per week. Then they will reduce the frequency down to once a week for a few more doses and then once a month.

Dr. Sederer:: And this is a ketamine infusion?

Dr. Mann: Yes, this generally has been a ketamine infusion. This approach seems to work quite well. But that may not be necessary.

Another strategy is to give one, two, or three doses of ketamine. If the patient doesn’t respond robustly to two or three doses, they’re not going to respond to subsequent doses.

Dr. Sederer: So, initial responses are a predictor of future response?

Dr. Mann: Exactly. Now, if they haven’t done well with two or three doses, then you’ve got to use other treatments. But if they do well with the two or three, then you’ve got a choice: You can either complete the treatment course with ketamine and then continue them on antidepressant medications, or simply treat them with ketamine alone. What we tend to do is to treat with only antidepressant medications after a small number of ketamine treatments. We also use ketamine as a kind of “rescue medication” if they relapse into severe depression, though this is true for only a minority of patients.

Dr. Sederer: One of the things that we’ve learned is that antidepressants have a very beneficial effect for some people, but then they wear out and the person starts to relapse. Should ketamine be studied as an intervention for people who are no longer responding to the antidepressant(s) that they are on?

Dr. Mann: We do not really know the answer to that question. My experience treating very seriously ill patients is that sometimes the ketamine will work very well the first time or the second time but then in the future, if you try to use it as a rescue medication, it might not work that well. There is some clinical experience that suggests that that may be true for some people. But we have no idea about the frequency or timing with which this might happen. That’s all uncertain.

Moreover, most of our control clinical trial data come from either one dose of ketamine or from a few trials where people have received multiple doses of ketamine, followed by a bit of a taper. But there are very, very few of those types of studies. We’re still learning about the use of this medication.

Dr. Sederer: Importantly, you referenced the side effects of antidepressants. What are the side effects and risks of ketamine?

Dr. Mann: We know a lot more about the immediate short-term side effects of a single dose or a few doses of ketamine. Most people will get a kind of tripping experience. They’ll feel a bit unreal, or their circumstances or experiences of the world feel a bit distorted.

Some patients develop strange ideas. Most patients don’t enjoy those symptoms, even though I know ketamine is used as a party drug, and so on and so forth.

Dr. Sederer: It seems that the context is what matters.

Dr. Mann: Yes. And in a clinic context, most patients simply don’t enjoy these types of dissociative experiences, but they put up with them. They’re not severe, in general.

Dr. Sederer: Is part of the preparation of the patient telling them that this may happen?

Dr. Mann: Yes. We try to explain the potential for these symptoms and that most people get them. These side effects almost invariably terminate with the cessation of the administration.

Dr. Sederer: What’s the typical duration of the infusion you use?

Dr. Mann: Traditionally, infusion is 40 minutes and always in a clinic setting.

Dr. Sederer: And that’s because of the concern that a patient may have these symptoms?

Dr. Mann: Exactly. They may have dissociative effects that they’re disturbed by, and we need to monitor that. They’re probably going to remain under observation in the clinic for about the same amount of time because it takes about the same time for these effects to wear off.

The other consideration is that some people get a little nausea. In our experience with the intravenous ketamine, there’s also a problematic side effect that their blood pressure will be slightly raised. Therefore, it’s good to know that the person’s blood pressure is under control before they begin the treatments and that you’re monitoring it during administration.

Dr. Sederer: What are the differences you’re discovering between esketamine and ketamine?

Dr. Mann: It is a bit different. We’ve just completed a very important National Institutes of Health–funded clinical trial here at Columbia showing that with esketamine or ketamine itself, the dose and the blood levels are very closely related to the robustness of the clinical response.

When you give a drug intravenously, you give a very reliable dose. When you give the drug over 40 minutes, you’re spreading the dose administration over a period of time so that it doesn’t peak very high. The side effects appear to be proportional to the peak dose.

When you give it intranasally, you give the drug over a much shorter period of time. Even if you use more than one intranasal administration to give the whole dose, it’s still a relatively shorter time, compared with the 40 minutes.

Dr. Sederer: This means that to get the equivalent dose intranasally, the patient is going to have to experience a higher peak. Can you predict that those patients who are treated intranasally are going to have more side effects?

Dr. Mann: Right. And that should be explained to the patient. You will not need an intravenous line inserted, which some people might find highly appealing and advantageous, but you will probably have more side effects.

Also, in general, intranasal absorption of drugs is more variable. The predictability of the blood level and, therefore, the degree of antidepressant effect is not as good intranasally as intravenously.

Now, all of this is anecdotal clinical experience, based on theoretical pharmacology, because nobody has actually done a head-to-head control comparison.

Dr. Sederer: What about the cost of both of these preparations?

Dr. Mann: There is a bit of a range in pricing between ketamine clinics around the country. It’s always important to find out what they charge per administration. And then it makes a difference whether you have two or three administrations versus six plus further tapered administration. Clearly, the cost can vary a great deal.

Dr. Sederer: But it’s generally not covered by insurance, so most people are paying out of pocket.

Dr. Mann: Yes. The intranasal ketamine is still in negotiation at the moment, but it should be resolved before it’s fully marketed.

Dr. Sederer: Ketamine is used for major depression. Does it have utility in bipolar depression?

Dr. Mann: We and some others have done initial studies in bipolar depression. In our view, it’s probably going to be as effective in bipolar disorder as it is in major depressive disorder, unipolar depression.

We haven’t seen any manic episodes triggered, but we don’t give repeated doses. We allow research patients to stay on anticonvulsants or mood stabilizers, so that’s helpful. Generally, people with bipolar disorder who come for ketamine treatment for their depression are coming on a mood stabilizer, because that and perhaps other conventional antidepressants have not proven to be effective. So, I think that ketamine plus mood stabilizers seems to be very promising.

Dr. Sederer: I want to return to the antisuicidal properties that you had previously mentioned. I heard from a colleague about a patient who had been admitted to a psychiatric inpatient unit. The patient was in her 20s; she did not have major depression but was persistently suicidal, constantly trying to hurt herself in any way she could. But that seemed to be more a product of borderline personality disorder, with its impulsive and self-destructive problems.

In the end, they tried intranasal ketamine. The response was, just as you described, robust. Her self-injurious behavior dropped in a very pronounced way within a day or two. But she then did require administrations a couple of times a week in order to keep that suicidality at bay.

Based on that example, I’m wondering whether there is an application here for people who are suicidal yet who may not have features of major depression or bipolar depression.

Dr. Mann: It’s a very interesting suggestion for which we have no data-based answer. However, we have a clue from the study that we published in the American Journal of Psychiatry and have since published further analyses on.

The reasons that people die by suicide, or make suicide attempts, are not entirely attributable to the fact that they suffer from a mood disorder.

Dr. Sederer: Yes, because only a minority of individuals with a mood disorder ever make suicide attempts. But there is a subgroup at risk.

Dr. Mann: Here at Columbia, we’ve promulgated the stress-diathesis model for suicidal behavior. A stressor could be external life events, but the internal stressor would be something like an acute episode of depression.

But predisposition also plays an important role, which has several elements to it. One is decision-making. These are patients with a propensity to go for a short-term, quick relief. In other words, a patient would be seeking immediate relief rather than waiting for the delayed improvement from an antidepressant. They’re more prone to act on the pain of the depression and terminate their lives – to try to end their pain – rather than wait and hope that, in time, there’s a chance that the antidepressant will work.

Dr. Sederer: What else do you want to share with our viewers about this medication and how it’s used?

Dr. Mann: My goal in treating patients is to try to use the least amount of medication possible. We do not really know yet the long-term safety of ketamine treatment.

It’s been used for many decades in anesthesia, but people don’t get repeated anesthetic doses of ketamine. And higher doses of ketamine given repeatedly have been shown in preclinical studies to produce little lesions in the brain, which is not good. But we’re using much lower doses.

As we potentially move into a time when we could be giving multiple doses of ketamine to patients, we should remember that we need to be cautious about that. If we don’t need to give them more doses, we shouldn’t. We should know that there is a potential downside that we don’t fully understand yet to giving ketamine repeatedly.

And that’s aside from its abuse potential. We know that people have employed ketamine for physical and emotional pain, and when they administer it themselves, they tend to get dependent on it. In a clinic setting it’s given in a very formal and structured fashion, a bit like the administration of opioids. In that setting, it is much safer and the risk for abuse and diversion is minimized. But we need to remember that this drug does have abuse potential and perhaps not yet fully measurable neurotoxic effects.

Dr. Sederer: If physicians, nurses, and other professional clinicians want to learn more about this medication, what are the accurate, reliable sources of information to which you suggest they turn?

Dr. Mann: The National Institute of Mental Health’s website offers good and reliable information for patients and their families. It is an unbiased, scientific, and thoughtful source of information, and better than just trolling the Internet for information.

People are much more sophisticated now than they were 20 years ago in these matters, and scientific papers are much more accessible to the public. Reading papers in recognized journals is also a useful way to gain information.

For example, one of the major papers that we published in the American Journal of Psychiatry is available to anybody on the Internet to read. So, I encourage people to make their own inquiries and talk to more than one doctor. Informed patients and families are the best partners a doctor can ever have. We encourage that in all of our patients.

Dr. Sederer: I want to thank you very much, Dr. Mann, for your work in this area and for joining us here at Medscape and Columbia Psychiatry to teach us so much about what is truly a novel psychopharmacologic agent, yet one where we still have a lot more to learn.

A version of this article originally appeared on Medscape.com.

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Adding a second-generation antipsychotic to an antidepressant to treat depression carries an increased mortality risk for middle-aged adults, results of a large, observational study show.

“Our study suggests physicians should consider prescribing antipsychotics to adults with depression carefully, as the potential health risks are substantial and the benefits are quite modest and controversially debated,” lead investigator Tobias Gerhard, PhD, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, N.J., said in a news release.

The results, he added, “emphasize the importance of considering newer antipsychotics only after nonresponse to less risky, evidence-based treatment options has been established.”

The study was published online September 30 in PLOS ONE.
 

A last resort

Previous research has demonstrated an increased mortality risk for elderly patients with dementia who take an atypical antipsychotic, but it’s unclear whether this risk occurs among nonelderly adults who use newer antipsychotics as augmentation treatment for depression.

To investigate, Gerhard and colleagues analyzed national healthcare claims from the Medicaid program from 2001 to 2010 for 39,582 Medicaid beneficiaries (mean age, 44.5 years; 78.5% women) who had been diagnosed with depression. Patients with alternative indications for antipsychotic therapy, such as schizophrenia, psychotic depression, or bipolar disorder, were excluded.

After at least 3 months of treatment with a single antidepressant, for more than half of the patients (56.6%), treatment was augmented with an atypical antipsychotic (quetiapine, risperidone, aripiprazole or olanzapine). For the remainder (43.4%), a second antidepressant was added.

The average chlorpromazine equivalent starting dose for all atypical antipsychotics was 68 mg/d. The dose was increased to 100 mg/d during follow-up.

A total of 153 patients died during 13,328 person-years of follow-up, including 105 for whom treatment was augmented with an atypical antipsychotic and 48 for whom treatment was augmented with a second antidepressant.

Compared to those who received a second antidepressant, among those for whom an antipsychotic was added, there was a 45% increased risk of dying during follow-up (adjusted hazard ratio, 1.45; 95% CI, 1.02 – 2.06).

This equates to an absolute risk difference of 37.7 deaths per 10,000 person-years of treatment (0.38% per year) and a number needed to harm of roughly 265 per year. For higher-risk subgroups, the number needed to harm decreased substantially, the authors note. The results were robust across several sensitivity analyses.

“We don’t know the mechanisms of the increased mortality risk, but cardiac and infectious causes are leading candidates,” said Gerhard.

“Our study in nonelderly adults with depression did not identify a single predominant cause of death. However, this may be a result of both the relatively small number of deaths in our study as well as of the well-recognized concerns regarding the accuracy of cause-of-death attribution in death certificates,” Gerhard said.

“As with the potential causes of death, the pathophysiological pathways involved are not well understood but could, among others, involve adverse metabolic effects, including weight gain, diabetes, dyslipidemia, QT prolongation, sedation, and falls – all of which have been associated with at least some of the newer antipsychotics,” he added.

The researchers state that atypical antipsychotics should be considered only “after non-response to evidence-based treatment options that are less risky.”
 

Another red flag

Commenting for Medscape Medical News, Timothy Sullivan, MD, chair of psychiatry and behavioral sciences at Northwell Health’s Staten Island University Hospital in New York, said this is a “valid contribution” and represents the second large study that “raises the same concern.”

“We’ve been probably underestimating the risk in administering them, and that’s something people really need to know, because if you’re prescribing it for someone with mild to moderate depression, it may be helpful, but is it really worth the risk if you’re significantly increasing their risk of death?” said Sullivan, who wasn’t involved in the study.

Clearly, he said, this “raises a flag that we have to look at this a little more carefully and be a little clearer with patients about the risk. One could argue that we should not be so quick to add these drugs, even though they could be helpful, before we exhaust other less potentially risky options.”

Sullivan’s advice: “Do the three trials of antidepressants, look at antidepressant combinations, don’t be quick to jump to this particular option, because of the concerns. Certainly there are situations like psychotic depression where the risk of use is outweighed by the benefits, given the clinical syndrome, but for less severe forms, we probably should reformulate some of our algorithms.”

The study was supported by the National Institute of Mental Health (NIMH). Gerhard received grants from the NIMH and the National Institute on Aging during the conduct of the study; grants and personal fees from Bristol-Myers Squibb; and personal fees from Eisai, Merck, Pfizer, Lilly, and IntraCellular Therapies outside the submitted work. Sullivan has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

A version of this article originally appeared on Medscape.com.

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

A version of this article originally appeared on Medscape.com.

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

A version of this article originally appeared on Medscape.com.