Friday, June 11, 2021

Lybalvi Approved for Schizophrenia, Bipolar I Disorder in Adults

The Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of schizophrenia in adults, Alkermes announced. The agency also approved Lybalvi for the treatment of bipolar I disorder in adults, as a monotherapy for maintenance, and as a monotherapy or an adjunct to lithium or valproate for the acute treatment of manic or mixed episodes.

Olanzapine is an antipsychotic, and samidorphan is a new chemical agent and an opioid antagonist. Lybalvi is taken once a day and may be taken with or without food. It will be available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.

The approval is based on data from the ENLIGHTEN clinical development program. In ENLIGHTEN-1, 403 patients who were experiencing an acute exacerbation of schizophrenia took either Lybalvi or placebo for four weeks. At the end of the study, those who had taken Lybalvi had statistically significant reductions from baseline in Positive and Negative Syndrome Scale scores compared with those who took placebo.

ENLIGHTEN-2 evaluated the weight-gain profile of Lybalvi compared with olanzapine over six months in 561 patients with stable schizophrenia. Patients who took Lybalvi had a lower mean percent weight gain at six months compared with those in the olanzapine group and a lower proportion of patients who gained 10%or more of their baseline body weight at six months. The difference in weight gain between the two groups became apparent after the fourth week of the trial, and their rates of weight gain continued to diverge for the remainder of the study. At the sixth week, weight stabilized in the Lybalvi group and remained flat for the rest of the study period.

Lybalvi has a boxed warning about increased mortality in older patients who have dementia-related psychosis. The warning also states that the medication is not approved for the treatment of patients with dementia-related psychosis.

Lybalvi should not be taken by patients who are taking opioids or who are experiencing acute opioid withdrawal. Prior to initiating Lybalvi, there should be at least a seven-day opioid-free interval from the last use of short-acting opioids and at least a 14-day opioid-free interval from the last use of long-acting opioids.

Potential side effects of Lybalvi include dry mouth, sleepiness, dizziness, increased appetite, and constipation.

For related information, see the American Journal of Psychiatry article “How Much of an Advance is the Addition of Samidorphan to Olanzapine?

Thursday, June 10, 2021

N.Y. State Program for First-Episode Psychosis Reduces Hospitalization, ER Use

Medicaid patients in New York state with a first episode of psychosis visited the emergency room and hospital significantly less after enrollment in the coordinated specialty care program OnTrackNY than prior to enrollment, according to a report in Psychiatric Services in Advance.

OnTrackNY is New York state’s early intervention program for individuals aged 16 to 30 who have experienced nonaffective psychosis for less than two years. With 23 sites throughout the state, OnTrackNY offers psychotherapy, medication management, family education and support, case management, and work and education support, depending on each individual’s needs and preferences. The Center for Practice Innovations at Columbia University, New York State Psychiatric Institute, and the New York State Office of Mental Health are partners in OnTrackNY.

“Notably, hospitalization rates have been shown to decrease during the first three months after OnTrackNY enrollment and remain relatively steady thereafter; the present study showed that these rates did not significantly increase during the first six months after discharge,” wrote Jennifer Humensky, Ph.D., of Columbia University Department of Psychiatry and New York State Psychiatric Institute and colleagues.

They compared rates of hospitalization and emergency room (ER) visits for 138 patients who were enrolled in OnTrackNY for at least six months and covered by Medicaid in the six months prior to program entry, the six months prior to OnTrackNY discharge, and the six months after OnTrackNY discharge.

In the pre-enrollment period, participants had an average of 1.45 ER visits, 0.80 inpatient visits, and 12.88 inpatient days. This use decreased to an average of 0.88 ER visits, 0.26 inpatient visits, and 3.7 inpatient days in the six months before discharge from OnTrackNY. Six months after discharge from ONTrackNY, the rates had not significantly changed: Patients had an average of 0.83 ER visits, 0.3 inpatient visits, and 4.9 inpatient days.

“Although more research is needed, particularly of larger populations and over a longer time frame, this study provides an initial indication that decreases in hospitalization and ER usage are maintained and do not significantly increase in the first six months after discharge from OnTrackNY,” the researchers concluded.

For related information, see the Psychiatric News article “Evidence Supporting Early Psychosis Treatment Grows as Programs Gain Ground in Communities.”

(Image: iStock/SDI Productions)

Wednesday, June 9, 2021

Matching Patients to Therapists’ Strengths Found to Improve Mental Health Outcomes

Patients who were matched to therapists with proven effectiveness in addressing the patients’ top areas of concern experienced greater improvements following treatment than those paired with therapists randomly, according to a study published today in JAMA Psychiatry.

“Mental illness is a major public health problem, and even among people who engage mental health care, more than 60% do not benefit meaningfully from care received,” wrote Michael Constantino, Ph.D., of the University of Massachusetts, Amherst, and colleagues. “These results suggest that measurement-based therapist report cards can help redirect [mental health care] toward therapists’ strengths.”

Constantino and colleagues conducted a trial across six clinics in Cleveland, Ohio, that included 48 therapists and 218 patients. To be included, the therapists had to provide outcome data from at least 15 cases, which were used to establish their performance profiles. Using 12 symptomatic or functional domains determined by the Treatment Outcome Package (TOP), the therapists were classified as effective (on average, their patients’ symptoms reliably improved), neutral (on average, their patients’ symptoms neither improved nor deteriorated), or ineffective (on average, their patients’ symptoms reliably deteriorated) within each of the domains. The TOP measures how much a patient has experienced 12 specific concerns in the past two weeks, including depression, quality of life, social conflict, substance misuse, suicidality, violence, and work functioning, among others. The TOP also measured patients’ impairment.

The patients in the 16-week trial completed the TOP to determine what interventions they needed. They were then randomly assigned to the matched group or the care-as-usual group. Those in the matched group were assigned to therapists who had proven effective in addressing the patients’ top three elevated domains as determined by their TOP results. Patients in the care-as-usual group were assigned to therapists through typical procedures, such as the therapist’s availability. The patients completed the TOP and the Symptom Checklist-10 (to measure psychological distress) at baseline and bi-weekly throughout the trial or the end of their treatment.

Patients in the matched group experienced greater reductions in their overall impairment compared with patients in the care-as-usual group. Though the matched group started treatment with higher impairment scores, on average, than the care-as-usual group, they ended the trial in the nonclinical range with an average score of about zero, which is the mean score for the general population. Impairment scores for patients in the care-as-usual group improved, but they still ended treatment in the clinically impaired range. Similarly, patients in the matched group experienced greater weekly reductions in psychological distress compared with patients in the care-as-usual group.

“Notably, the good fit in this study came not from changing what the therapists did in their treatment, but rather who they treated,” the authors wrote. “Capitalizing on whatever it is that a therapist historically does well when treating patients with certain mental health problems, the current data indicate that our match system can improve the effectiveness of that care, even with neither therapist nor patient being aware of their match status.”

For related information, see the American Journal of Psychotherapy article “Patient Choice in Depression Psychotherapy: Outcomes of Patient-Preferred Therapy Versus Randomly Allocated Therapy.”

(Image: iStock/KatarzynaBialasiewicz)

Tuesday, June 8, 2021

Alzheimer’s Antibody Therapy Receives Accelerated Approval Amid Controversy

The Food and Drug Administration (FDA) yesterday granted accelerated approval to the monoclonal antibody aducanumab for the treatment of Alzheimer’s disease.

Alzheimer’s disease is characterized by changes in the brain—which include beta-amyloid plaques and neurofibrillary, or tau, tangles—that result in the loss of neurons and their connections.

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA’s accelerated approval pathway is designed to speed up the approval of medications for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. The pathway enables drug companies to provide a surrogate biomarker that they believe can reasonably suggest future clinical benefit. In the case of aducanumab, accelerated approval was granted based on data from three clinical studies (including two phase 3 studies) demonstrating a significantly greater reduction of beta-amyloid plaques in patients with early stage Alzheimer’s disease who took aducanumab compared with those who took placebo.

The phase 3 data on the effects of aducanumab on cognition were inconclusive. Though one of the phase 3 trials found that patients who received aducanumab had a slightly slower cognitive decline than those who received placebo, the other phase 3 trial did not. In fact, an FDA advisory panel voted nearly unanimously in November 2020 that the clinical data supporting aducanumab were not sufficient to warrant approval.

“Under the accelerated approval provisions, … the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug,” the FDA release stated.

The approval of aducanumab quickly sparked debate among clinicians, researchers, and advocacy groups. Many scientists believe that the approval—even conditional—is premature.

“The most compelling argument for approval was the unmet need, but that cannot, or should not, trump regulatory standards,” said Caleb Alexander, M.D., a professor of epidemiology at Johns Hopkins University and member of the FDA advisory panel, in a news article. “It’s hard to find any scientist who thinks the data are persuasive.”

Malaz Boustani, M.D., M.P.H., the Richard M. Fairbanks Chair of Aging Research at Indiana University School of Medicine and a research scientist at the Regenstrief Institute, gave a more optimistic view in an interview with Psychiatric News. Though the data are not yet conclusive, he noted that the safety profile of aducanumab was favorable relative to other antibody-based medications such as those used in chemotherapy. Given the tremendous health care burden of Alzheimer’s, he said that he believes the benefit-harm ratio supported a conditional approval.

“I think this approval could also have a ripple effect in improving Alzheimer’s recognition,” Boustani said. “Currently, we miss anywhere from 50% to 80% of patients with Alzheimer’s because brain scans are not routinely provided as a standard of care.” Now that an early stage Alzheimer’s treatment exists, physicians may be more willing to recommend scans for patients, which can help confirm the type of neurodegeneration a patient is experiencing, he said.

For related information, see the Psychiatric News article “New Report Suggests Alzheimer’s Prevalence May Triple by 2050.”

(Image: iStock/wenht)

Monday, June 7, 2021

APA Honors Rep. Bonnie Watson Coleman for Her Work to Improve Mental Health Care

APA has selected Rep. Bonnie Watson Coleman (D-N.J.) as this year’s winner of its Jacob K. Javits Award for Public Service for her commitment and dedication to increase patient access to mental health and substance use disorder services.

The Javits Award recognizes a federal and/or state public servant who has made outstanding contributions to the mental health community. It honors the legacy of Sen. Jacob K. Javits of New York, who achieved many successes on behalf of those with mental illness. The award was presented this past weekend during APA’s online federal advocacy conference.

“Rep. Watson Coleman’s leadership is critical to our nation’s mental health,” said APA President Vivian Pender, M.D., in an APA news release. “Her focus on health equities goes beyond simply funding the services that are needed, but to a wider lens of understanding how social determinants are impacting the mental health of diverse communities around the nation.”

In 2018, Watson Coleman convened a congressional hearing to discuss suicides among Black youth after data revealed that their suicide death rate was increasing faster than in other racial/ethnic groups. The following year, Watson Coleman helped to establish the Congressional Black Caucus (CBC) Emergency Taskforce on Black Youth Suicide and Mental Health. The task force created a work group of Black mental health experts and advocates to identify the causes driving this crisis and possible solutions (past APA President Altha Stewart, M.D., was a member of this work group). In December 2019, the task force released a comprehensive report titled “Ring the Alarm: The Crisis of Black Youth Suicide in America.” In conjunction with the release of the report, Watson Coleman introduced the Pursuing Equity in Mental Health Act of 2019 (HR 5469), a bill aimed at addressing disparities in access, care, and study of mental health issues among people of color. The bill passed the House but did not get a vote in the Senate. This past March, Watson Coleman and Rep. John Katko (R-N.Y.) reintroduced the Pursuing Equity in Mental Health Act (HR 1475). This bill is strongly supported by APA.

Watson Coleman, who is serving her fourth term in the U.S. House of Representatives, is the first Black woman to represent New Jersey in Congress. Before her election to the House, Watson Coleman served eight consecutive terms in the New Jersey General Assembly, where she became the first Black woman to serve as majority leader and chair of the New Jersey Democratic State Committee. She is also the first Black woman to win the Javits Award.

“I’m deeply honored to receive the Javits Award. I am also grateful to the APA for their efforts in fighting youth suicide,” Watson Coleman said. “When I formed the Congressional Black Caucus’s Emergency Taskforce on Black Youth Suicide and Mental Health, I immediately recognized the seriousness of the work we were doing. … I was also humbled by the outpouring of support and resources by the mental health community including organizations like the American Psychiatric Association and recognize that the work we’ve accomplished so far would not have been possible without their efforts.”

“I’m so pleased APA is presenting Rep. Watson Coleman with this award,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “She is such an important ally in Congress for us and for all people with mental illness and substance use disorders, and her leadership is bringing real, positive change to communities.”

For related information, see the Psychiatric News articles “Congress Considering Bills to Curb Black Youth Suicide” and “Alarming Black Youth Suicide Trend Must Be Addressed, Experts Say.”

Looking to Learn More About Apps?

Join members of App Advisor’s Expert Panel tomorrow, Tuesday, June 8, at 3 p.m. ET, for a webinar on HIPAA Privacy and Security Rules and how they relate to the use of apps for patient care. Experts will discuss the use of Business Associate Agreements between clinicians and app developers and more. For the second part of this event, registrants are asked to pre-submit questions about the App Evaluation Model. Presenters will respond to these questions and, if there is time, address other questions using the Q&A feature of Zoom.


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Friday, June 4, 2021

Medical Students Often Perceive Lack of Respect for Diversity Among Faculty

Nearly 18% of graduating medical students who responded to a survey in 2016 and 2017 perceived that medical school faculty show a lack of respect for diversity, a study published today in JAMA Network Open has found.

“Our observation that a perceived lack of respect was prevalent among medical students may reflect students’ perceptions regarding faculty-patient interactions, their experiences within the overall learning environment, and the direct social interaction or lack thereof between students and faculty,” wrote Jasmine Weiss, M.D., of Yale School of Medicine and colleagues. “During each clinical encounter in a teaching context, faculty should exemplify respectful interpersonal communication and effective patient engagement despite differences in culture, beliefs, and background.”

Weiss and colleagues analyzed data from 28,778 graduating medical students who responded to the Association of American Medical Colleges’ 2016 and 2017 Medical School Graduation Questionnaire, which was administered to graduating students at 140 medical schools in the United States.

Overall, 17.7% of the respondents reported perceiving that faculty showed a lack of respect for diversity. Students who identified as Black/African American had 3.24 times the odds of perceiving a lack of respect for diversity among faculty compared with White students. Those who identified as American Indian/Alaska Native/Native Hawaiian/Pacific Islander, Asian, or Hispanic/Latinx also had greater odds of perceiving a lack of faculty respect for diversity compared with White students. Female students had greater odds of perceiving a lack of faculty respect for diversity compared with male students; and students who identified as lesbian, gay, or bisexual or whose sexual orientation was unknown had greater odds of perceiving a lack of faculty respect for diversity compared with heterosexual students. Students aged 33 years or older had greater odds of reporting perceived lack of faculty respect for diversity compared with students aged 26 years or younger.

“This perceived lack of respect for diversity has important implications for patient care, the learning environment, and social interactions with trainees,” the researchers wrote. “Further studies are needed to assess the mediators of students’ perceptions of faculty respect for diversity and how these perceptions may more directly impact student well-being as well as to identify optimal interventions to improve role modeling of respect for diversity among faculty.”

For related information, see the American Journal of Psychiatry articles “Dismantling Structural Racism in Academic Psychiatry to Achieve Workforce Diversity” and “Psychiatry Diversity Leadership in Academic Medicine: Guidelines for Success.”

(Image: iStock/SDI Productions)

Thursday, June 3, 2021

FDA Authorizes Marketing of New Aid to Diagnose Autism

Yesterday, the Food and Drug Administration (FDA) authorized marketing of a new device meant to help in the diagnosis of autism spectrum disorder (ASD), according to a news release. The Cognoa ASD Diagnosis Aid uses a machine learning algorithm to aid physicians when evaluating patients from 18 months through 5 years of age who are at risk of ASD.

According to the Centers for Disease Control and Prevention, ASD is estimated to affect 1 in 54 children in the United States. The disorder can be difficult to diagnose as symptoms can vary, which can delay treatment and early interventions. The average age of diagnosis is 4.3 years, according to the FDA.

“Autism spectrum disorder can delay a child’s physical, cognitive, and social development, including motor skill development, learning, communication, and interacting with others,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in the release. “The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin.”

The ASD Diagnosis Aid allows parents, caregivers, and health care professionals to input details about their children or patients, then the software processes the information to make a diagnosis. It consists of three components: a mobile app that allows parents and caregivers to upload videos of their children and answer questions about behaviors; a video analysis portal through which certified specialists view and analyze uploaded videos; and a portal for physicians and other health care professionals to answer questions about patients’ behavior problems, track information about them, and review the software’s diagnostic report. The device issues reports that the child is positive or negative for ASD to help determine a diagnosis or that there is insufficient information.

A study compared the device’s assessments of ASD diagnoses among 425 patients aged 18 months to 5 years against assessments made by a panel of clinical experts. The ASD Diagnosis Aid provided a positive or negative result for ASD for 32% of patients. The device matched assessments made by the panel of clinical experts for 81% of patients who tested positive and 98% of patients who tested negative.

According to the release, the device accurately made an ASD determination in 98.4% of patients with ASD and 78.9% of patients without the disorder. The device provided a false positive result in 15 out of 303 patients without ASD and a false negative in 1 out of 122 patients with ASD.

“The Cognoa ASD Diagnosis Aid is indicated as an aid in the diagnosis of ASD for patients 18 months through 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process,” the release concluded.

For related information, see the American Journal of Psychiatry article “Variable Emergence of Autism Spectrum Disorder Symptoms From Childhood to Early Adulthood.”

Wednesday, June 2, 2021

ECT, Medication Combo Found as Safe as Medication Alone to Maintain Remission From MDD

Older adults being treated for depression with a combination of electroconvulsive therapy (ECT) and medication appear to have similar cognitive improvements over time as those treated with medication only, according to a report in the American Journal of Geriatric Psychiatry.

Sarah Lisanby, M.D., director of the Noninvasive Neuromodulation Unit at the National Institute of Mental Health, and colleagues looked at neurocognitive outcomes in adults aged 60 and over enrolled in the multicenter Prolonging Remission in Depressed Elderly (PRIDE) study. A 2016 analysis of that study, which appeared in the American Journal of Psychiatry, found that patients receiving a combination ECT and medication for six months experienced greater improvements in mood compared with those who received pharmacotherapy alone.

For the current study, Lisanby and colleagues examined six-month neurocognitive outcomes for a total of 120 patients with remitted depression who received either a combination of ECT (right unilateral ultrabrief pulse ECT), venlafaxine, and lithium or venlafaxine and lithium only as part of the PRIDE study. The researchers used standard instruments to assess attention and processing speed, verbal fluency, verbal learning and memory, memory of personal events in one’s own life, and executive functions.

With the exception of processing speed, there was statistically significant improvement across most neurocognitive measures from baseline to six-month follow-up for both groups of patients—those who received ECT, venlafaxine, and lithium as well as those who received medication alone. There were no significant differences between the two treatment groups at six months on measures of psychomotor processing speed, autobiographical memory consistency, short-term and long-term verbal memory, phonemic fluency, inhibition, and complex visual scanning and cognitive flexibility.

“Our key finding is that neurocognitive function improved over the six-month follow-up period,” Lisanby and colleagues wrote. “Given that [the combination of ECT, venlafaxine, and lithium] was more effective in sustaining antidepressant remission than [medication alone] without increasing the risk of neurocognitive side effects, these results support the use of [the combination of ECT, venlafaxine, and lithium] to prolong remission from depression,” Lisanby and colleagues wrote.

Lisanby and colleagues acknowledged that some of the patients in the study could have cognitive difficulties following the six-month time point. “Future research is warranted to examine the longer term cognitive, and antidepressant, trajectory,” they wrote.

For related news, see the Psychiatric News article “Older Patients With Depression May Benefit From ECT, Medication Combo.”


Tuesday, June 1, 2021

U.S. Youth Increasingly Aware of Dangers of E-Cigarettes

U.S. youth appear more aware of the dangers of e-cigarettes than they were just five years ago, according to a report in the American Journal of Preventive Medicine. The findings suggest that efforts to educate adolescents about e-cigarettes may be working and point to groups of adolescents who may need additional support.

Joseph L. Rapp, M.P.H., Karen M. Wilson, M.D., Ph.D., and colleagues at the Icahn School of Medicine at Mount Sinai analyzed data collected between 2015 and 2019 from the National Youth Tobacco Survey. This survey is given to U.S. middle- and high-school students annually.

In addition to assessing the number of students who had smoked cigarettes or used e-cigarettes in the past 30 days, the researchers specifically focused on how the students responded to the following two survey questions:

  • “How much do you think people harm themselves when they smoke e-cigarettes some days, but not every day?” (Response options: no harm, a little harm, some harm, and a lot of harm)
  • “Do you believe that e-cigarettes are less, equally, or more addictive than cigarettes?” (Response options: less addictive, equally addictive, more addictive, I have never heard of e-cigarettes, and I don’t know enough about these products)

The sample included 83,779 students (average age 14.5 years). While there was a slight drop in the percentage of students who reported smoking cigarettes over time (5.78% in 2015 compared with 3.93% in 2019), there was a significant increase in the percentage of students who reported using e-cigarettes during that period (10.77% in 2015 compared with 19.80% in 2019).

Students’ perceptions of the harm associated with vaping increased over time: In 2015, 23.58% believed occasional e-cigarette use caused a lot of harm compared with 32.21% in 2019. Similarly, students’ perception of the addictiveness of e-cigarettes compared with cigarettes also increased: In 2016 (the first year this question was asked), 7.26% said they considered e-cigarettes to be more addictive than cigarettes; by 2019, 26.31% of students considered e-cigarettes to be more addictive.

Female and non-White students were more likely to think that e-cigarettes were at least as addictive as cigarettes but also reported less knowledge about e-cigarettes, the researchers noted. They also found that minority students were more likely than their non-Hispanic White peers to perceive that intermittent use of either E-cigarettes or cigarettes was not as harmful as daily use.

“Concerted efforts should be made to expand education about e-cigarettes and should be combined with stringent regulations on their sale and advertisement,” they concluded.

For related information, see the Psychiatric News article “FDA Bans Some Flavored E-Cigarettes, but Advocates Say Policy Falls Short.”

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