RecruitingMajor Depression
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Eligible age
18–75 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 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)
- ✓ MADRS \>/= 20 at baseline
- ✓ Failure to respond satisfactorily to \>/= 2 antidepressant treatments for \>/= 8 weeks, including \>/= 2 weeks at an adequate dose (\>/= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.
- ✓ If applicable, concurrent \& permitted antidepressants must be at stable doses for \>/= 4 weeks prior to baseline (see allowed \& prohibited medication list)
- ✓ Participants of child-bearing potential must have negative pregnancy test \& agree to adhere to a medically acceptable method of birth control during the study
You may not qualify if…
- ✕ 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)
- ✕ Severe alcohol and/or cannabis use disorder within the past 6 months (mild or moderate alcohol and/or cannabis use is allowed at the discretion of the LSI)
- ✕ Lifetime hallucinogen persisting perception or hallucinogen use disorders
- ✕ Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past XX months
- ✕ Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol
Where it's recruiting
Source: ClinicalTrials.gov · NCT07226232 · last updated 2026-08-14