The U.S. Department of Veterans Affairs announced the launch of a new clinical trial to evaluate the effectiveness and safety of psilocybin to treat major depression in Veterans, including those with concurrent post-traumatic stress disorder (PTSD).

This new trial aligns with the current Administration’s focus on advancing research into innovative treatments for serious mental health conditions, including post-traumatic stress disorder (PTSD), depression, and substance use disorders.

The randomized, controlled trial will enroll Veterans diagnosed with treatment-resistant major depressive disorder, with or without concurrent PTSD, and will compare outcomes between two psilocybin dosage levels. The study will also assess participants’ levels of depression before and after treatment, tolerability of side effects, and overall patient-reported depression.

The trial will be conducted in a safe, controlled, clinical setting using pharmaceutical-grade drugs under careful quality controls, stringent safety protocols that were developed with FDA, and in a setting that includes psychological support.

In addition to this trial, VA is involved in 20 active clinical trials focused on psychedelic therapies for mental health conditions. All VA research — including research into psychedelics – is conducted under strict safety protocols and in full compliance with federal guidelines.

The U.S. Food and Drug Administration has granted breakthrough therapy designation to several companies developing psychedelic substances, including MDMA, psilocybin and LSD, allowing for expedited review of these drugs. Clinical use of these therapies outside of research will only be considered by VA once FDA approval is granted.