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RECRUITING
NCT07570654
PHASE2/PHASE3

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

Sponsor: COMPASS Pathways

View on ClinicalTrials.gov

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.

Official title: A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-09

Completion Date

2029-09

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

COMP360 psilocybin

COMP360 psilocybin administered with monitoring and support

Locations (8)

FL

Miami, Florida, United States

FL

Orlando, Florida, United States

IL

Chicago, Illinois, United States

MN

Eden Prairie, Minnesota, United States

NE

Lincoln, Nebraska, United States

NV

Las Vegas, Nevada, United States

NY

New York, New York, United States

BC

North Vancouver, British Columbia, Canada