The Department of Veterans Affairs has launched PIVOT, a multi-site clinical trial testing psilocybin for veterans with treatment-resistant major depressive disorder, including those with PTSD. The study will compare two dosage levels across five VA centers and operate under strict safety and monitoring protocols. Researchers will measure depression scores, patient-reported outcomes and adverse effects before and after treatment. The trial is part of an effort to expand research into psychedelic-assisted therapies.
VA Launches PIVOT Trial Testing Psilocybin for Veterans With Treatment-Resistant Depression
FILE - A laboratory technician displays mushrooms that contain psilocybin, a hallucinogenic substance on Thursday, July 13, 2023. (Photographer: Moriah Ratner/Bloomberg via Getty Images)
The U.S. Department of Veterans Affairs has launched a multi-site clinical trial to evaluate whether psilocybin is safe and effective for veterans diagnosed with major depressive disorder that has not responded to standard treatments, including veterans who also have post-traumatic stress disorder (PTSD).
Big picture
The study, named Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression (PIVOT), will compare two dose levels of psilocybin and monitor participants closely for safety and clinical outcomes. The VA says the trial is part of a broader effort, tied to a recent executive order, to expand clinical trial participation and accelerate research into psychedelic-assisted therapies.
What officials say
"Far too many veterans are living with mental health conditions that don't respond to available treatments," the VA said in a statement. "This clinical trial reflects another step toward evaluating new treatments and offering meaningful relief to those who have served."
Where the trial will take place
The trial will be conducted at five VA sites, each operating under strict safety and monitoring protocols with medical oversight, standardized dosing procedures and follow-up care:
- Birmingham VA Health Care System and Tuscaloosa VA Medical Center (Alabama)
- VA Portland Health Care System (Oregon)
- Corporal Michael J. Crescenz VA Medical Center (Philadelphia, Pennsylvania)
- Puget Sound Health Care System (Seattle, Washington)
Study details: Who and what will be measured
PIVOT will enroll veterans diagnosed with treatment-resistant major depressive disorder, with or without concurrent PTSD. Researchers will randomize participants to one of two psilocybin dose levels and will assess clinical outcomes using standardized depression rating scales, patient-reported outcomes, and safety monitoring for adverse effects. The study will track depression scores before and after treatment and include follow-up visits to assess durability of response and any side effects.
How to learn more
For additional information, interested veterans and clinicians can consult the VA News release and the study listing on ClinicalTrials.gov for enrollment criteria, site contacts, and study timelines.
Sources
Information for this report was taken from the VA news release and ClinicalTrials.gov. This story was reported from San Jose.
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