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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04433858
The ClinicalTrials.gov registry entry for NCT04433858 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (93% lower). The listed sponsor is Sheppard Pratt Health System, which has 10 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.