The Department of Veterans Affairs has launched a clinical trial examining whether psilocybin can safely and effectively treat veterans with major depression that has not responded to existing therapies.
The randomized, controlled study, called Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression, or PIVOT, will enroll veterans diagnosed with treatment-resistant major depressive disorder. Participants may also have post-traumatic stress disorder.
Researchers will compare outcomes from two dosage levels while measuring changes in depression, treatment side effects and participants’ assessments of their symptoms.
“Far too many Veterans are living with mental health conditions that don’t respond to available treatments,” VA Secretary Doug Collins said. “Under President Trump, VA is pursuing all avenues to evaluate new treatments and offer meaningful relief for those who have worn the uniform.”
The trial follows President Donald Trump’s executive order, “Accelerating Medical Treatments for Serious Mental Illness,” which calls for expanding clinical-trial participation and accelerating research and drug-approval models involving psychedelic substances.
Research will take place at five VA facilities, including the VA Portland Health Care System in Oregon and VA Puget Sound Health Care System in Seattle. Additional sites are located in Birmingham and Tuscaloosa, Alabama, and Philadelphia.
The VA said participants will receive pharmaceutical-grade psilocybin in controlled clinical settings with psychological support. Safety procedures were developed with the Food and Drug Administration, according to the department.
The PIVOT study is one of 20 active VA clinical trials examining psychedelic therapies for mental-health conditions. The FDA has granted breakthrough-therapy designation to companies developing treatments involving psilocybin, MDMA and LSD, allowing those products to receive an expedited review process.
The VA said it will not consider using psychedelic therapies in routine clinical care unless they receive FDA approval. The department also warned veterans against self-medicating with psychedelics or replacing established mental-health treatments with unprescribed substances.
The study is registered with ClinicalTrials.gov under identification number NCT07226232.
About the Author
Discover more from Right Now Oregon
Subscribe to get the latest posts sent to your email.
