WASHINGTON, D.C. — The U.S. Department of Veterans Affairs is launching a randomized clinical trial of psilocybin for veterans with treatment-resistant major depressive disorder, including participants with concurrent post-traumatic stress disorder, expanding federal research into psychedelic therapies for serious mental illness.
The study, called Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression, or PIVOT, will compare outcomes between two psilocybin dosage levels.
Researchers will assess changes in depression before and after treatment, side-effect tolerability and patient-reported depression outcomes.
“Far too many Veterans are living with mental health conditions that don’t respond to available treatments,” VA Secretary Doug Collins said. “This clinical trial reflects another step toward this goal.”
The trial will be conducted at five locations, including the Corporal Michael J. Crescenz VA Medical Center in Philadelphia.
Other sites are the Birmingham VA Health Care System and Tuscaloosa VA Medical Center in Alabama, VA Portland Health Care System in Oregon, and VA Puget Sound Health Care System in Seattle.
The VA said the study will use pharmaceutical-grade psilocybin in controlled clinical settings with psychological support and safety protocols developed with the U.S. Food and Drug Administration.
The trial follows President Donald Trump’s executive order on “Accelerating Medical Treatments for Serious Mental Illness,” which calls for expanded clinical-trial participation and research into psychedelic drugs.
The VA is already involved in 20 active clinical trials examining psychedelic therapies for mental health conditions.
The FDA has granted breakthrough therapy designation to several companies developing psychedelic substances, including psilocybin, MDMA and LSD, allowing for expedited review.
The VA said it would consider clinical use of such therapies outside research only after FDA approval.
The agency also cautioned veterans against self-medicating with psychedelics or replacing existing treatments with unprescribed substances.
The PIVOT trial is registered at ClinicalTrials.gov under NCT07226232.
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