The Week in Review: March 4-8

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This week, Psychiatric Times® discussed a wide variety of psychiatric issues and industry updates, from an update on Prism for PTSD to the efficacy of home-use transcranial direct current stimulation for MDD.

FDA Grants Breakthrough Designation to MM-120 for Generalized Anxiety Disorder

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The US Food and Drug Administration has granted breakthrough designation to MindMed’s lysergide d-tartrate program (MM-120) for the treatment of generalized anxiety disorder (GAD). Additionally, MindMed released 12-week topline data showing its phase 2b study of MM-120 in GAD met its key secondary endpoint and had statistically significant durability of activity observed through week 12.

“I’ve conducted clinical research studies in psychiatry for over 2 decades and have seen studies of many drugs under development for the treatment of anxiety. That MM-120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable,” stated David Feifel, MD, PhD, professor emeritus of Psychiatry at the University of California, San Diego; director of the Kadima Neuropsychiatry Institute; and an investigator in the MM-120 study. Continue Reading

Home-Use Transcranial Direct Current Stimulation for a Major Depressive Episode

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tDCS is a non-invasive brain stimulation modality with evidence for moderate efficacy in major depressive disorder (MDD). It involves the application of low currency through multiple scalp electrodes, which modulate neuronal excitability and neuroplasticity.

Advantages of tDCS compared with other neurostimulation treatments are greater portability, and lower cost, and fewer adverse effects. However, tDCS requires daily administration. Therefore, at-home use of tDCS would increase scalability and enable more widespread adoption. Continue Reading

Study Highlights Efficacy of Prism for PTSD in Alleviating Chronic PTSD Symptoms

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A study explored the efficacy of the neurofeedback therapy, Prism for PTSD, in the treatment of posttraumatic stress disorder (PTSD). The study aimed to explore the safety and effectiveness of Prism in alleviating symptoms of chronic PTSD, particularly in individuals who have not responded to standard treatments.

Prism—the first self-neuromodulation device for PTSD approved by the US Food and Drug Administration (FDA) that officially launched in the United States in January 2024—operates as a software device developed by GrayMatters Health Ltd. It utilizes neurofeedback, a form of brain training that involves real-time monitoring of brain activity through electroencephalogram (EEG) signals. Continue Reading

STAR*D’s Cumulative Remission Rate and Why It Still Matters

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The well-written Psychiatric Times article concluded, “it is urgent for the field of psychiatry to reconcile the significant differences in remission rates for patients with [major depressive disorder; MDD] as published in the original STAR*D article in 2006 with the reanalysis just published in the BMJ article this year.” And we agree.

As was noted, if our reanalysis of STAR*D’s patient-level data set is correct—that STAR*D’s cumulative remission rate was only approximately half of that reported in 2006—this is a major setback for psychiatry, “as all of the publications and policy decisions based on the STAR*D findings that became clinical dogma since 2006 will need to be reviewed, revisited, and possibly retracted.” Continue Reading

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