The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.
Veteran of the U.S. military who is English-speaking
Signed informed consent and HIPAA
Adults </= 75 years of age
Meets DSM-5 criteria for current major depressive episode (MDE)
Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders
First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder
Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)
Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)
VA Office of Research and Development
Lead sponsor