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NCT05733546 · ClinicalTrials.gov registry record · Phase 2

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

A Phase 2 study of Major Depressive Disorder, sponsored by COMPASS Pathways.

Active
Registry status
Phase 2
Development phase
102
Enrollment target
5
Study locations

NCT05733546: Active Phase 2 study of Major Depressive Disorder, sponsored by COMPASS Pathways.

NCT05733546 is a Phase 2 study of Major Depressive Disorder that is active but no longer recruiting, run by COMPASS Pathways. The registered enrollment target is 102 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (73% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05733546, a Phase 2 study of Major Depressive Disorder, is active but no longer recruiting, sponsored by COMPASS Pathways.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
102 participants
Enrollment target
5
Study locations

Study Summary

Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.

Primary Outcome

Proportion of patients with adverse events (AEs)

Conditions Studied

Interventions

  • DRUG Psilocybin

Study Locations (5)

California

  • Kadima Neuropsychiatry Institute - La Jolla

Florida

  • Clinical Neuroscience Solutions Inc - Jacksonville

Maryland

  • Sunstone Therapies - Rockville

Massachusetts

  • Elixia MA, LLC - Springfield

Texas

  • Aims Trial - Plano

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2023-01-30
Est. Completion 2025-09
Phase Phase 2
COMPASS Pathways

8 total trials

What the registry record for NCT05733546 still lists

NCT05733546 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.

NCT05733546 lists 5 locations in 5 states (California, Florida, Maryland).

Frequently Asked Questions

What is clinical trial NCT05733546 about?

NCT05733546 is a clinical study titled "A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder". Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.

What is the current status of trial NCT05733546?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2023-01-30. Estimated completion is 2025-09.

What conditions does trial NCT05733546 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT05733546?

The interventions under investigation include: Psilocybin (DRUG).

Who is sponsoring clinical trial NCT05733546?

This trial is sponsored by COMPASS Pathways, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05733546 being conducted?

This trial has 5 study locations across California, Florida, Maryland, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Major Depressive Disorder

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 NCT05733546's enrollment target sits among peer trials

102 131st of 282 higher than 152 of 282 other Major Depressive Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Major Depressive Disorder 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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Source: ClinicalTrials.gov NCT05733546, the US trial registry maintained by the National Library of Medicine. NCT05733546 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.