The Week in Review: September 18-22

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from violence risk assessment in emergency departments to connections between bipolar disorder and substance use disorders. Here are some highlights from the week.

Phase 3 Study Supports Efficacy, Safety of New Chemical Entity for MDD

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Results from a long-term phase 3 study supported the efficacy and safety of a new chemical entity (NCE) for the treatment of major depressive disorder (MDD).

The study—a long-term, open-label, registrational, non-comparative trial known as Study 310—evaluated the safety and efficacy of REL-1017 administered once-daily in patients with MDD over a period of up to 1 year. In it, the investigators found that patients experienced fast, clinically meaningful, and sustained improvements in symptoms of depression and related functional impairment. They also found that REL-1017 was well-tolerated over the course of long-term dosing; noted low rates of adverse events and adverse event-related discontinuations; and detected no additional safety signals. Continue Reading

Violence Risk Assessment in the Emergency Department

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Although substantial progress has been made over the past several decades by mental health professionals to undertake suicide risk assessment with more structured approaches, violence risk assessment has lagged despite emerging evidence that highlights violence as a significant issue.

Violence has become an increasingly recognized problem in health care. Rates of violent behavior toward health care workers, especially frontline workers such as nursing staff, are high. Emergency departments (EDs) are notable for their high rates of violent incidents. A recent meta-analysis found that 77% of ED workers were subject to some form of workplace violence. Continue Reading

How Do Treatments for Bipolar Disorder and SUD Affect One Another?

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An expert gave a presentation on the connections between bipolar disorder and substance use disorders (SUDs) at the 2023 University of New Hampshire (UNH) Department of Nursing Psychiatric-Mental Health Nurse Practitioner (PMHNP) program’s inaugural Psychopharmacology Conference on September 16.

In the presentation, speaker Stephanie Nichols, PharmD, MPH, BCPS, BCPP, FCCP, described the epidemiology of SUDs in patients with bipolar disorder; discussed some common etiologies between SUDs and bipolar disorder, including genetic, environmental, and socioeconomic factors; and shared some ways SUDs impact the treatment of bipolar disorder and some ways bipolar disorder impacts the treatment of SUDs. Nichols is an associate professor at the University of New England School of Pharmacy. Continue Reading

The Future of Clinical Trials: Diversity, Transparency, and Reform

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Clinical trials are vital to the development of new drugs and treatments, but they are not without controversy. In recent years, there have been several high-profile cases where clinical trials have been called into question due to issues with transparency, diversity, and other ethical concerns. One such case involved the controversial clinical trial of the drug aducanumab, which the US Food & Drug Administration (FDA) approved in 2021 despite questions about its efficacy and safety.

The aducanumab controversy has highlighted the need for greater transparency and reform in the clinical trial process. One area that requires particular attention is the lack of diversity in clinical trials. Studies have shown that clinical trials often do not reflect the demographics of the populations that will ultimately use the drug or treatment being tested. This can result in treatments that are less effective for specific populations or that have unexpected adverse effects. Continue Reading

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