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NCT04433858 · ClinicalTrials.gov registry record · Phase 2
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
A Phase 2 study of Treatment-Resistant Depression, sponsored by Sheppard Pratt Health System.
- Active
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 2
- Study locations
NCT04433858: Active Phase 2 study of Treatment-Resistant Depression, sponsored by Sheppard Pratt Health System.
NCT04433858 is a Phase 2 study of Treatment-Resistant Depression that is active but no longer recruiting, run by Sheppard Pratt Health System. The registered enrollment target is 27 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04433858, a Phase 2 study of Treatment-Resistant Depression, is active but no longer recruiting, sponsored by Sheppard Pratt Health System.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (2)
California
- VA Palo Alto Healthcare System/Stanford Medicine - Palo Alto
Maryland
- Sheppard Pratt Health System - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
What the registry record for NCT04433858 still lists
NCT04433858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT04433858 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04433858 about?
NCT04433858 is a clinical study titled "An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)". The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.
What is the current status of trial NCT04433858?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-03-01. Estimated completion is 2026-05-01.
What conditions does trial NCT04433858 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT04433858?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT04433858?
This trial is sponsored by Sheppard Pratt Health System, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04433858 being conducted?
This trial has 2 study locations across California, Maryland. 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 NCT04433858's enrollment target sits among peer trials
27 39th of 54 higher than 16 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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