Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Psilocybin for Major Depression

The purpose of this multi-site randomly assigned controlled trial is to measure the how well it works and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

Official registry: https://clinicaltrials.gov/study/NCT07226232 · VA Office of Research and Development · enrollment listed as 240

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin, or Psilocybin. The registry lists allocation as randomized. The purpose of this multi-site randomly assigned controlled trial is to measure the how well it works and risks of psilocybin for the treatment of depression in U.S.

They plan to enroll about 240 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans

Interventions: Psilocybin, Psilocybin

Primary outcome (registry wording): Montgomery-Asberg Rating Scale (MADRS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Veteran of the U.S. military who is English-speaking
  • Adults \</= 75 years of age
  • Meets DSM-5 criteria for current major depressive episode (MDE)
  • Montgomery-Asberg Rating Scale (MADRS)\>/= 20 at baseline
  • 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
  • Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration

Public study contact (from the registry)

Lori L Davis, MD AB

(205) 554-3819

lori.davis@va.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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FAQ about this NCT record

Is NCT07226232 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07226232?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07226232?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary