Recruiting

Phase 2

Phase 3

COMP360Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Sponsor:

COMPASS Pathways

Code:

NCT07570654

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD

PTSD Symptoms

PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COMP360 psilocybin

Study Details

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD

PTSD Symptoms

PTSD, Post Traumatic Stress Disorder

Study ID

NCT07570654

Start date

Sep, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1 mg COMP360 psilocybin

experimental: 10 mg COMP360 psilocybin

experimental: 25 mg COMP360 psilocybin

Interventions

COMP360 psilocybin

COMP360 psilocybin administered with monitoring and support

Primary outcome measure

COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Redefine Study Call Center

202-459-9258 TheRedefineStudy@compasspathways.com

Locations

Florida

Recruiting

Orlando, Florida, United States, 32801

Recruiting

New York, New York, United States, 10025

More Information

Sponsor

COMPASS Pathways

Last update posted

Sep 4, 2026

Last verified

Apr, 2026

Keywords

COMP360
psilocybin
Redefine
PTSD
trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by COMPASS Pathways on 2026-09-04.