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Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

Study acronym: PIVOT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jul 30, 2026 to Aug 3, 2026 · Eligibility criteria revised · Study description revised · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Jul 30, 2026 to Aug 3, 2026
    • Eligibility criteria revised
    • Study description revised
    • Site details revised at 5 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jun 1, 2026 to Jul 30, 2026 Completion date: Apr 30, 2031 to Jun 30, 2031 · Eligibility criteria shortened, about 2 wordsv2 Show 2 more changesShow less
    • Completion date: Apr 30, 2031 to Jun 30, 2031
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07226232
Lead Sponsor VA Office of Research and Development
Conditions Major Depression
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov