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NCT05624268 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
A Phase 3 study of Treatment-Resistant Depression, sponsored by COMPASS Pathways.
- Active
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
- 20
- Study locations
NCT05624268: Active Phase 3 study of Treatment-Resistant Depression, sponsored by COMPASS Pathways.
NCT05624268 is a Phase 3 study of Treatment-Resistant Depression that is active but no longer recruiting, run by COMPASS Pathways. The registered enrollment target is 255 participants, below the 369-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05624268, a Phase 3 study of Treatment-Resistant Depression, is active but no longer recruiting, sponsored by COMPASS Pathways.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
- 20
- Study locations
Study Summary
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
Primary Outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (20)
California
- ProScience Research Group - Culver City
- Collaborative Neuroscience Network, LLC - Garden Grove
- Kadima Neuropsychiatry Institute - La Jolla
- University California San Diego - La Jolla
- California Center for Psychedelic Therapy - Los Angeles
- CalNeuro Research Group, Inc - Los Angeles
- Clarity Clinical Research, LLC - Los Angeles
- ATP Clinical Research, Inc. - Orange
- Artemis Institute for Clinical Research - San Diego
- Lumos Clinical Research Center - San Jose
- Stanford University - Stanford
- ASCLEPES Research Centers - Thousand Oaks
Florida
- Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare - Orlando
- APG Research, LLC - Orlando
- DMI Health Care Group, Inc - Tampa
- Meridien Research/Accel Research - Tampa
Georgia
- Psych Atlanta - Atlanta
- Emory University - Atlanta
Arizona
- University of Arizona College of Medicine - Tuscon - Tucson
Connecticut
- Comprehensive Psychiatric Care - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT05624268 still lists
NCT05624268 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 369-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (31% 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.
NCT05624268 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05624268 about?
NCT05624268 is a clinical study titled "Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD". Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
What is the current status of trial NCT05624268?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2023-01-19. Estimated completion is 2026-04.
What conditions does trial NCT05624268 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT05624268?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT05624268?
This trial is sponsored by COMPASS Pathways, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624268 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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 NCT05624268's enrollment target sits among peer trials
255 10th of 54 higher than 45 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
-
Psilocybin-Assisted Therapy in Treatment-Resistant Depression
RECRUITING · Phase 3
-
Biomarker-guided rTMS for Treatment Resistant Depression
RECRUITING · Phase 3
-
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
ACTIVE NOT RECRUITING · Phase 3
-
A Study in Relapse Prevention of Treatment-Resistant Depression
COMPLETED · Phase 3
-
Open-Label Safety Study of AXS-05 in Subjects With Depression
COMPLETED · Phase 3
-
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
RECRUITING · NA
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