Clinical Trial

Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-07
notable Enrollment reduced: 23 -> 20 participants 2026-05-07
notable Primary completion moved earlier: 2026-06 -> 2026-04-09 2026-05-07
minor Completion moved earlier: 2027-06 -> 2027-03-26 2026-05-07
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 2024-04-19
Primary Completion 2026-04-09 (estimated)
Study Completion 2027-03-26 (estimated)
Updated on ClinicalTrials.gov 2026-05-06