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Psilocybin-Assisted Therapy in Treatment-Resistant Depression

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Enrollment reduced: 23 → 20 participants · Primary completion moved earlier from Jun 2026 to Apr 9, 2026 · Completion moved earlier from Jun 2027 to Mar 26, 2027 · 1 morev8 Show 4 more changesShow less
    • Enrollment reduced: 23 → 20 participants
    • Primary completion moved earlier from Jun 2026 to Apr 9, 2026
    • Completion moved earlier from Jun 2027 to Mar 26, 2027
    • Site details revised
  2. Eligibility criteria expanded, about 15 wordsv7 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Sep 2025 to Jun 2026 Enrollment target: 20 to 23 · Completion date: Sep 2026 to Jun 2027 · Eligibility criteria expanded, about 6 words · 1 morev6 Show 4 more changesShow less
    • Enrollment target: 20 to 23
    • Completion date: Sep 2026 to Jun 2027
    • Eligibility criteria expanded, about 6 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Site contact updatedv5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Apr 2024 to Apr 19, 2024v3
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 2024 to Apr 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Mar 2024 to Apr 2024
    • Site details revised
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.
Trial Details
NCT Number NCT06303739
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Foundation of Hope, North Carolina
Conditions Refractory Depression, Treatment Resistant Depression
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov