The Department of Veterans Affairs announced a formal clinical trial evaluating the safety and effectiveness of psilocybin-assisted therapy for veterans with major depression, including those with concurrent post-traumatic stress disorder, on Aug. 5.
The VA recently signed a memorandum of understanding with HHS on coordinating psychedelic drug trial research, the department said. The trial targets veterans with treatment-resistant depression who have not responded to existing antidepressants or psychotherapy.
Psilocybin, the psychoactive compound found in certain mushrooms, remains a Schedule I controlled substance under federal law. Clinical trial authorization requires Drug Enforcement Administration approval, which the VA secured for the study.
The trial represents a historic shift in federal policy toward psychedelic medicine. The VA is the nation’s largest integrated health care system, serving more than 9 million enrolled veterans, and its endorsement of a psilocybin trial carries significant weight in the medical research community.
Veteran suicide remains an urgent public health concern. An average of 17.5 veterans die by suicide each day, according to the most recent VA data. Depression and PTSD are among the leading risk factors.
Existing treatments for depression — including selective serotonin reuptake inhibitors and talk therapy — fail to produce adequate improvement in an estimated 30 percent of patients, a population described as treatment-resistant.
Early clinical research at academic institutions has shown promising results for psilocybin in treating depression, but the VA trial would be among the first large-scale studies conducted within the federal health care system. Results could open pathways to broader adoption if the therapy proves safe and effective.