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NCT06303739 · ClinicalTrials.gov registry record · Phase 3
Psilocybin-Assisted Therapy in Treatment-Resistant Depression
A Phase 3 study of Treatment-Resistant Depression and Refractory Depression, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT06303739: Recruiting Phase 3 study of Treatment-Resistant Depression and Refractory Depression, sponsored by University of North Carolina, Chapel Hill.
NCT06303739 is a Phase 3 study of Treatment-Resistant Depression and Refractory Depression that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 23 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06303739, a Phase 3 study of Treatment-Resistant Depression and Refractory Depression, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The change in Hamilton Depression Rating Scale 17 item (HAM-D-17) scores between baseline and 2 weeks after treatment The HAM-D-17 is a 17-item questionnaire used to measure severity of depression. The score ranges from 0 to 52. Higher scores indicate more severe depression.
Conditions Studied
Interventions
- DRUG psilocybin
Study Locations (1)
North Carolina
- UNC Chapel Hill Medical Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What NCT06303739 shows while recruiting
NCT06303739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which psilocybin is the first listed.
NCT06303739 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06303739 about?
NCT06303739 is a clinical study titled "Psilocybin-Assisted Therapy in Treatment-Resistant Depression". 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 tre...
What is the current status of trial NCT06303739?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2024-04-19. Estimated completion is 2027-06.
What conditions does trial NCT06303739 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression, Refractory Depression.
What interventions are being tested in trial NCT06303739?
The interventions under investigation include: psilocybin (DRUG).
Who is sponsoring clinical trial NCT06303739?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06303739 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06303739's enrollment target sits among peer trials
23 40th of 54 higher than 15 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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