Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Psilocybin
  • Psilocybin

Treatment groups

240 Participants
are divided into 2 treatment groups