Wednesday, November 24, 2021

Cognitive-Behavioral Therapy for Insomnia May Prevent Depression in Older Adults

Cognitive-behavioral therapy for insomnia (CBT-I) may help to prevent depression in older adults with insomnia disorder, according to a report published today in JAMA Psychiatry.

“Insomnia, occurring in nearly 50% of persons 60 years or older, contributes to a 2-fold greater risk of major depression,” wrote Michael R. Irwin, M.D., of the David Geffen School of Medicine at UCLA and colleagues. “In this trial of older adults without depression but with insomnia disorder, delivery of CBT-I prevented incident and recurrent major depressive disorder by more than 50% compared with [sleep education therapy], an active comparator.”

CBT-I—a first-line treatment for insomnia disorder—combines cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation. Sleep education therapy (SET) teaches about the day-to-day behavioral and environmental factors that contribute to poor sleep.

For the study, Irwin and colleagues enrolled 291 adults 60 years or older who lived within 15 miles of UCLA and met DSM-IV criteria for insomnia disorder. Individuals with a history of depression could participate in the study, but those who had experienced depression within the past year were excluded.

The 291 participants (including 123 with a history of depression) were randomized to receive either CBT-I or SET in weekly two-hour group sessions for two months. The participants were evaluated monthly using the Patient Health Questionnaire (PHQ-9) and every six months using the Structured Clinical Interview of the DSM-5 for 36 months.

Incident or recurrent major depression occurred in 19 participants in the CBT-I group (4.1 events per 100 person-years) and 35 participants in the SET group (8.6 events per 100 person-years). The proportion of participants who achieved remission of insomnia disorder after treatment was greater in the CBT-I group (50.7%) compared with the SET group (37.7%). Similarly, a greater proportion of participants in the CBT-I group achieved sustained remission of insomnia (defined as the absence of insomnia disorder at each follow-up assessment) compared with those in the SET group: 26.3% vs. 19.3%.

“This study indicates that an intervention aimed at insomnia can effectively reduce the incidence of major depression in those without a depressive disorder at the start of the intervention, meaning that depression can be prevented effectively without even using the word depression and thus avoid the associated stigma,” Pim Cuijpers, Ph.D., of Vrije Universiteit Amsterdam and Charles F. Reynolds III, M.D., of the University of Pittsburgh School of Medicine wrote in an accompanying editorial. “If prevention of major depression can be realized by focusing on insomnia, would it be possible to prevent depressive disorder by focusing on other problems that are associated with depression?”

Cuijpers and Reynolds added, “This major finding offers exciting new opportunities for the prevention field and opens a new field of research into indirect preventive interventions for avoiding the stigma of mental disorders.”

For related information, see the American Journal of Psychiatry article “The Evolving Nexus of Sleep and Depression.”

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Tuesday, November 23, 2021

Lithium Does Not Appear to Lower Risk of Suicidal Behavior in Veterans With Mood Disorders

Adding lithium to the treatment plan of veterans with depression or bipolar and recent suicidal behavior does not appear to reduce the risk of subsequent suicidal behavior, according to a report in JAMA Psychiatry.

“The present double-blind, placebo-controlled study found no benefit of lithium over placebo for preventing or delaying suicide-related events (suicide attempts, interrupted attempts, hospitalizations to prevent attempts, or deaths from suicide) when it was added to usual VA mental health management,” wrote Ira R. Katz, M.D., Ph.D., emeritus professor of psychiatry at the University of Pennsylvania Perelman School of Medicine, and colleagues. “However, lithium still has a role in the management of mood disorders, especially bipolar disorder.”

Veterans at 29 VA medical centers who had an episode of suicidal behavior or an inpatient admission to prevent suicide within the past six months were randomized to receive lithium or placebo in addition to their existing medications and treatment. Individuals were included in the study if they had a DSM-IV-TR diagnosis of major depression or bipolar disorder; they were excluded if they had schizophrenia, six or more lifetime suicide attempts, or had used lithium within the past six months.

Katz and colleagues tracked the occurrence of any suicide-related events in the participants for one year.

The trial was halted for futility after 519 participants had been randomized (255 with lithium and 264 with placebo), as the data indicated no difference in suicide-related events between the participants who received lithium and those who received placebo. A total of 127 participants (24.5%) had suicide-related outcomes: 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group.

The authors cautioned that their data had some notable limitations, including that only half of participants assigned to lithium achieved clinically adequate blood levels of the medication (0.5 mEq/L or higher).

“Our findings are not necessarily generalizable to other health care settings or to other patient populations with differing proportions of individuals with bipolar disorder, lower rates of comorbidities, or higher treatment adherence,” Katz and colleagues wrote.

In an accompanying editorial, Ross J. Baldessarini, M.D., and Leonardo Tondo, M.D., M.S., of Harvard Medical School suggest that the report should be read with the study limitations in mind. “In our opinion, this rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk.”

They added, “The new trial did not find evidence of an antisuicidal effect of adding lithium to complex treatment regimens in relatively small numbers of mostly male veterans with complex, although realistic, psychopathological conditions, given relatively brief treatment with low circulating levels of lithium. Thus, its findings cannot be taken as evidence that lithium lacks antisuicidal effects.”

For related information, see the Psychiatric Services article “Suicide Mortality Among Veterans Health Administration Care Recipients With Suicide Risk Record Flags.”

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Monday, November 22, 2021

FDA Temporarily Suspends Some Clozapine REMS Program Requirements

The Food and Drug Administration (FDA) has temporarily suspended certain requirements of the recently modified Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program after the agency received reports of challenges with the program. The Clozapine REMS is a safety program required by the FDA to manage patients’ risk of neutropenia associated with clozapine treatment.

“Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS program, including a high call volume and long call wait times for stakeholders since launch of the program on November 15,” the FDA wrote in a statement. “We understand that this has caused frustration and has led to patient access issues for clozapine. … Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”

The temporary changes mean that pharmacists may dispense clozapine without REMS dispense authorization and wholesalers may continue to ship clozapine to pharmacies and health care settings without confirming REMS enrollment.

Patients who abruptly stop using clozapine can experience significant physical and behavioral symptoms, including the potential re-emergence of psychosis.

If you are having problems with the Clozapine REMS, please contact the APA Practice Helpline or SMI Adviser.

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Friday, November 19, 2021

House Passes Build Back Better Act to Invest in Mental Health, Substance Use Disorder Care

Today the U.S. House of Representatives passed the Build Back Better Act, a $2 trillion spending package that includes significant investments in mental health and substance use disorder (SUD) care.

APA applauds the inclusion of these provisions in the legislation:

  • Enforcement of mental health parity laws: The 2008 federal parity law requires that insurance coverage for mental health and SUD services be no more restrictive than coverage for other medical care, but there has yet to be full compliance with this law. The legislation would levy civil monetary penalties for violating parity law requirements.
  • Expansion of the behavioral health workforce: The legislation would fund 4,000 new, Medicare-supported graduate medical education slots in 2025 and 2026, the largest increase in more than 25 years, and it would allocate 15% of the new residency slots to psychiatry and other behavioral health training programs. Furthermore, it would provide $75 million in funding to award grants to establish or expand programs to enlarge and diversify the maternal mental health and SUD treatment workforce. It would also provide an additional $50 million for the SAMHSA Minority Fellowship Program in which APA participates.
  • Enhancement of crisis services: The legislation would make permanent an increase in Medicaid funding for mobile crisis response. It would also include $75 million in funding for the National Suicide Prevention Lifeline to help expand programs as the Lifeline transitions to the new 988 number next summer.
  • Increased access to care: The legislation would provide 12 months of continuous eligibility to children enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) and permanently extends the state option. It would also invest in Medicaid by extending coverage to women 12 months after giving birth, permanently enhancing federal funding for the territories, and covering people 30 days prior to leaving jail or prison. In addition, the legislation would boost access to care through Certified Community Behavioral Health Care Clinics and would expand tax credits for purchasing insurance through the Affordable Care Act marketplaces.

APA urges the Senate to ensure that these provisions are retained in the final reconciliation package.

For more information, see the Psychiatric Services article “Supporting the Mental Health Workforce During and After COVID-19.”

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Thursday, November 18, 2021

Drug Overdose Deaths Reach Record High During Pandemic

Drug overdoses killed more than 100,000 people in the United States during the one-year period ending in April 2021, according to provisional data issued yesterday by the Centers for Disease Control and Prevention (CDC). This marks the first time that drug overdose deaths reached six figures in one year and represents a 29% increase in overdose deaths from the prior year.

Synthetic opioids (that mimic the effects of natural opioids like heroin but are far more potent), primarily fentanyl, were responsible for 64% of the total deaths, a rise of nearly 50% from the year before, according to the CDC’s National Center for Health Statistics. Psychostimulants, such as methamphetamine, were responsible for 28% of the total deaths.

APA, responding to this news, renewed its call for the following actions:

  • Improved access to mental health and substance use services through early identification, utilizing evidence-based models that integrate behavioral health treatment into primary care services.
  • Effective substance use disorder treatment for all patients, through the development of science-based policies that are based on a thorough review and discussion with Congress, federal policymakers, and experts in the field of addiction treatment.
  • Policies and programs to support accredited medical schools and residency programs to provide training for the treatment of individuals with substance use disorders and incentivize more educators, consultants, and physician leaders to take on roles to develop an addiction workforce.

White House Response

The White House Office of Drug Control Policy also yesterday issued a model law states may adopt to expand access to the emergency opioid agonist naloxone, which can reverse opioid overdoses. At present, naloxone access is largely dependent on where one lives, according to Rahul Gupta, M.D., director of National Drug Control Policy.

“This model law provides states with a framework to make naloxone accessible to those who need it—an evidence-based solution that, according to research, would have a significant effect on reducing opioid-related overdose deaths,” Gupta said in a media release.

The model law aims to be a template for state legislatures. It would require health insurers to cover naloxone, encourage citizens to obtain it, protect individuals from unjust prosecution for administering it, and increase access in educational and correctional settings.

Last month, the Department of Health and Human Services released an overview of the Biden administration’s plan to combat drug overdoses. It includes measures designed to remove barriers to prescribing medication for opioid use disorder; reduce stigma; and provide new funding for prevention, evidence-based treatment and recovery support, and harm reduction. President Biden’s proposed fiscal year 2022 budget for drug-related programs and initiatives totals $11.2 billion, a 54% increase over this year’s budget.

For related information, see the Psychiatric News article “Drug Overdoses Surge Due to Pandemic, Early Reports Show.”

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Wednesday, November 17, 2021

Low-Dose, Off-Label Exposure to Some Antipsychotics May Increase Risk of Cardiometabolic Death

People taking off-label, low doses of the antipsychotics olanzapine or quetiapine for more than six months may be at higher risk of death due to cardiometabolic complications than people not taking these medications, according to a report in the Journal of Psychiatric Research.

“Off-label” use of antipsychotics (meaning prescribing an FDA-approved drug for an unapproved use) has become extremely common, despite limited evidence of effectiveness, wrote Jonas Berge, M.D., of Lund University in Sweden and colleagues. Additionally, studies have shown that olanzapine and quetiapine are associated with cardiometabolic complications—obesity, dyslipidemia, hyperglycemia, hypertension—that can lead to death.

Using Swedish national registries, the researchers identified adults 18 years and older who had at least one psychiatric visit (inpatient or outpatient) between July 2006 and December 2016. People who had previous diagnoses of bipolar, psychotic, or cardiometabolic disorders and/or who were prescribed antipsychotics or drugs indicated for cardiometabolic-related reasons prior to the study period were excluded from the analysis. A total of 428,525 individuals (average age: 37 years) were followed for 10.5 years; of these, 18,317 were treated with low-dose olanzapine or quetiapine, defined as 5 mg/day or less. By the end of the study, 13,358 of the cohort died during the observation time.

Berge and colleagues compared cardiometabolic death outcomes in those taking low-dose olanzapine or quetiapine for six months or less, six to 12 months, and more than 12 months.

In total, 2,606 cardiometabolic-related deaths occurred. Compared with no treatment, treatment for less than six months was associated with a significantly lower risk of cardiometabolic death. However, people treated for six to 12 months had a 1.89 times higher risk of cardiometabolic death than those not treated. (There was a slightly higher risk of death for those treated more than 12 months, but it was not statistically significant.)

Among those treated, each year of exposure to an average dosage of 5 mg/day was associated with a 1.45 times higher risk of death, according to the report.

“Clinicians ought to be aware of potential cardiometabolic consequences [of off-label exposure to low-dose olanzapine or quetiapine],” the researchers wrote. “Before prescribing, a thorough risk-benefit analysis should be performed, with screening and follow-up being well employed regardless of prescribed dose or length of treatment.”

For related information, see the Psychiatric News article “Special Report: Guidance on Managing Side-Effects of Psychotropics.”

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REIMAGINE: A Week of Action to Reimagine National Response to People in Crisis

APA is pleased to be a partner in REIMAGINE: A Week of Action to Reimagine Our National Response to People in Crisis, which kicked off Monday and continues through Friday, November 19. Each day features different speakers and topics, with the goal of exploring the impact of our current inadequate response to people in crisis and how to advocate to change things for the better. Please participate and invite others in your district branch to participate as well.


Tuesday, November 16, 2021

COVID-19 Survivors With Depression Respond to SSRIs Within 4 Weeks, Small Study Suggests

People who develop major depression following a COVID-19 infection appear to respond to treatment with selective serotonin reuptake inhibitors (SSRIs) within four weeks, according to a small study reported in European Neuropsychopharmacology.

“After COVID-19, depression was reported in 40% of patients at one-, three-, and six-months’ follow-up,” wrote Mario Gennaro Mazza, M.D., of Vita-Salute San Raffaele University in Milan, Italy, and colleagues. “The host immune response to SARS-CoV-2 infection and the related severe systemic inflammation seems to be the main mechanism contributing to the development of post-COVID depression.”

The study included 60 adults (average age: 55 years) who developed a major depressive episode within six months following recovery from COVID-19 and were starting a new SSRI treatment; 26 were treated with sertraline, 18 with citalopram, 10 with paroxetine, four with fluvoxamine, and two with fluoxetine. The researchers evaluated the patients using the Hamilton Depression Rating Scale (HDRS) at the beginning of the study and after four weeks of SSRI treatment.

After four weeks, average HDRS among the patients dropped from 23.37 to 6.71, with similar improvements seen in men and women as well as people with or without a history of psychiatric illness. Fifty-five of the 60 patients (92%) achieved a clinical response to antidepressant treatment, defined as ≥50% reduction in HDRS score. For comparison, studies in the general population have shown that depressed patients tend to respond to an antidepressant about 40% to 60% of the time, the authors wrote.

“SSRI treatment could contribute to the rapid antidepressant response by directly targeting the neuroinflammation triggered by SARS-CoV-2,” they wrote.

While the authors acknowledged the limitations of the study (including the lack of a control group and the small sample size), they suggested that the findings point to the importance of routinely screening COVID-19 survivors for depression so they can be promptly treated.

For related information, see the Psychiatric News article “Antidepressants May Reduce Severity of COVID-19.”

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REIMAGINE: A Week of Action to Reimagine National Response to People in Crisis

APA is pleased to be a partner in REIMAGINE: A Week of Action to Reimagine Our National Response to People in Crisis, which kicked off yesterday and continues through November 19. Each day features different speakers and topics, with the goal of exploring the impact of our current inadequate response to people in crisis and how to advocate to change things for the better. Please participate and invite others in your district branch to participate as well.



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