Trial Profile

A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 20 Dec 2025

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At a glance

Drugs Psilocybin (Primary)
Indications Major depressive disorder; Treatment-resistant depressive disorder
Focus Registrational; Therapeutic Use
Acronyms COMP005
Sponsors COMPASS Pathways

Most Recent Events

05 Nov 2025 According to an Atai Beckley media release, the ATAI Life Sciences has merged with Beckley Psytech to form Atai Beckley.
04 Nov 2025 According to a COMPASS Pathways media release, company now plans to disclose 26-week data (Part B) from COMP005 in Q1 2026.
23 Jun 2025 Primary endpoint(COMP360 25 mg versus placebo for the change from baseline in MADRS total score) has been met.

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