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NCT04656301 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT04656301: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT04656301 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04656301, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.
Primary Outcome
The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.
Interventions
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-26 |
| Est. Completion | 2022-11-02 |
| Phase | Phase 2 |
What the finished NCT04656301 record still lists
NCT04656301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Psilocybin is the first listed.
NCT04656301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04656301 about?
NCT04656301 is a clinical study titled "Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder". In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a...
What is the current status of trial NCT04656301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-02-26. Estimated completion is 2022-11-02.
What interventions are being tested in trial NCT04656301?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT04656301?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04656301's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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