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RecruitingPhase 2 / Phase 3

Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

NCT07570654 · Redefine · COMPASS Pathways

Recruiting
Status
Accepting participants
Phase 2 / Phase 3
Phase
300
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score

    Measured over 8 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 18 years or older * Diagnosed with PTSD at least 6 months ago Exclusion Criteria: \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions

Where

1 study site

FacilityCityRegionCountry
NYNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07570654 on ClinicalTrials.gov →

Last updated in the registry 2026-08-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits