FDA Approves 6-month Dose of Schizophrenia Drug

What’s Happening

The FDA approved the long-acting injectable (LAI) atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate, Janssen/Johnson & Johnson) as a twice-yearly treatment for adults with schizophrenia. This is the first and only approved 6-month treatment for the condition. Before using Invega Hafyera, patients must successfully trial one of J&J’s other LAIs: Invega Sustenna (1-month paliperidone palmitate) for at least 4 months, or Invega Trinza (3-month paliperidone palmitate) for at least one 3-month injection cycle. A randomized, double-blind, non-inferiority Phase 3 study (n=702) found that 92% of participants were relapse-free at 12 months, which demonstrated Hafyera’s non-inferiority with Trinza. Hafyera’s safety profile is consistent with those of the 1- and 3-month paliperidone palmitate formulations.

Why it’s Noteworthy

LAIs remove the burden of a patient having to remember to take daily medication, and a twice-yearly medication could help patients move toward “a life less defined by schizophrenia medication” as a company release states. The American Psychiatric Association encourages the use of LAIs in its recently updated practice guideline for the treatment of schizophrenia.

Reports & Perspectives

  • NIH’s DailyMed provides an info sheet about the drug.
  • In a study by Bhatta et al, adults with schizophrenia or schizoaffective disorder were less likely to have an encounter with the criminal justice system after starting LAI antipsychotic treatment compared with a similar timeframe before initiating LAI treatment.
  • Relapse prevention was the topic of a study by Leucht et al, who evaluated the efficacy of lower doses of antipsychotics to treat schizophrenia in a meta-analysis. Looking at 26 studies including 4776 participants, the team found that doses higher than approximately 5-mg daily of risperidone (or equivalent) were not associated with more efficacy, and they could cause more adverse events.
  • @LindaLMimms (board member for the Schizophrenia & Psychosis Action Alliance) tweeted, “A twice a year long acting injectable from Janssen, Invega Hafyera, has been approved by the FDA for the treatment of schizophrenia. This has the potential to be a game changer in medication adherence and management of this serious brain disease.”

Some people also shared thoughts on the name of J&J’s new drug:

  • @KJBinSTL (Kevin J. Black, professor of psychiatry at Washington University School of Medicine in St. Louis) tweeted, “Finally a drug name that actually is clever and easy to remember: ‘Invega Hafyera’ (paliperidone palmitate that is given only twice a year, i.e., every Half Year).”
  • @cherndon12 (Chris Herndon, PharmD, professor at the SIUE School of Pharmacy) tweeted, “Seriously, the drug companies are just getting lazy now. Invega ‘Hafyera’ for their new 6-month paliperidone injection. Too funny…”

In Practice

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Can social support mediate the relationship between personality traits and physical functioning in African Americans? Lijing Ma answers.

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Suicidal Thoughts on the Rise in Girls and Teens with No Mental Health History

What’s Happening

A cross-sectional study by Ridout et al found that incidence rates in 2020 of emergency department (ED) visits for suicidal thoughts or behaviors in youth aged 5 to 17 years were comparable to rates from 2019, with some specific variations by population. At the start of the pandemic, rates dropped from March to May 2020 compared to this timeframe in 2019, which was likely due to shelter-in-place orders, the authors wrote. From June to December 2020, however, rates significantly increased for girls compared to 2019, while suicide-related ED visits for male youth decreased from September 1 through December 15, 2020. The researchers found that from September to December 2020, youth with no previous mental health treatment or suicide-related encounters, as well as youth with comorbid psychiatric disorders, had more ED visits compared to this time period in 2019.

Ridout’s team used data from Kaiser Permanente Northern California, a large, integrated, community-based health system, which recorded a total of 2,123 suicide-related ED visits for youth in 2020, and 2,339 such visits in 2019.

Why it’s Complicated

As Suicide Prevention Awareness Month (September) continues, it’s important to remember that suicide is the second leading cause of death in youth aged 10 to 17 years, and that strategies to change this statistic are urgently needed. The authors suggested that preventive efforts – such as mental health screening, psychoeducation, support in connecting to care, and technology-based care ­– may be beneficial to youth and their families.

Reports & Perspectives

  • See Kaiser Permanente’s report on the study and interview with lead author Kathryn Erickson-Ridout, MD, PhD.
  • Predicting suicide attempts and deaths in adolescents using machine learning models was studied by Penfold et al, who found that data that were routinely collected by electronic health records and insurance claims could be used to predict suicide risk in adolescents. See the article by Dr. Penfold about youth suicide and how to use what we know about predicting who needs help to prevent deaths.
  • A report from KWGS Public Radio Tulsa discusses Oklahoma’s high youth suicide rate, which in 2019 was about double the national average, and that suicide became the leading cause of death for 10- to 17-year-olds in the state at that time. The article explores the concern that the pandemic may be pushing this rate higher, and notes that hospitals have reported increased in youth suicide-related visits.
  • @kpnorcal (Kaiser Permanente Northern California) tweeted, “Sharing the importance of suicide prevention and ways you can spot the signs. Thanks to Dr. Kathryn Erickson-Ridout for speaking to @abc7newsbayarea about World Suicide Prevention Week.”
  • @KWGSNEWS (KWGS, Public Radio Tulsa) tweeted, “In a regular state survey of sixth through 12th grade students, one in 10 of the 89,000 kids who completed it said they attempted suicide in the past 12 months.”
  • @RTI_Intl (nonprofit research center RTI International) tweeted, “‘Black youth suicide is on the rise, but our effort to understand the how and why is not keeping pace.’ @abryantmiller co-authored an @JAMAPediatrics article calling for a ‘Ground Zero’ approach. #WorldSuicidePrevention.”
  • @JAMANetworkOpen tweeted, “Harmful online activities precede risk of suicide and self-harm behaviors in US students. The greatest risk is evident for youths demonstrating multiple types of online risk factors.”

In Practice

Social Support Linked to Physical Function in Black Adults

What’s Happening

A two-wave longitudinal study by Clark et al in the Journal of Black Psychology found that social support can mediate the relationship between certain personality traits and physical functioning. Data were collected from a national probability sample of African American adults (n=312). Using telephone surveys, the five-factor model personality traits (Big Five) were assessed at Time 1 (T1) while social support and physical functioning were assessed 2.5 years later at Time 2 (T2). Researchers found that T2 social support mediated the relationship between T1 personality traits and T2 physical functioning for conscientiousness, extraversion, agreeableness, and neuroticism, but not for the trait of openness to experience.

Why it’s Noteworthy

The authors wrote that these findings may help mental health professionals and community members better understand the role of social support in prevention and treatment programs. In future studies, they suggest other personality traits be evaluated.

Reports & Perspectives

  • A previous study by Clark and some of the same members of the above research team investigated the moderating role of the Big Five personality traits on the relationship between social capital and depressive symptoms in African Americans.
  • Research by Mihalache & Mihalache examined the relationship between workplace support, personality traits, and employees’ job-related well-being during the COVID-19 pandemic.
  • The mediating effects of social support on the relationships between the Big Five personality traits and the social well-being of Chinese residents were evaluated in a study by Yu et al.
  • A study by Su et al found that social support from friends helped protect against excessive drinking in people who were at risk of alcohol use disorder due to genetic predisposition and sensation-seeking personality traits.
  • @DrJinniSu (lead author on the above study and professor at ASU) tweeted, “Check out this news story covering our recent research – genetic risk and sensation seeking may increase risk for drinking, but strong social support can buffer the risk.”
  • @jclinnursing (Journal of Clinical Nursing) tweeted, “Workplace bullying, personality traits and health among hospital nurses: The mediating effect of social support.”

In Practice

Last Updated: Sep 23, 2021