RecruitingPhase 2 / Phase 3NCT07570654
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
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. (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Conditions
- PTSD - Post Traumatic Stress Disorder; PTSD; PTSD Symptoms; PTSD, Post Traumatic Stress Disorder
- Intervention
- COMP360 psilocybin
- Sponsor
- COMPASS Pathways
- Ages
- 18 Years and over
- Sex
- All
- Healthy volunteers
- No
- Enrolment
- 300 people (planned)
- Start
- September 2026
- Primary completion
- November 2028
- Registry last updated
- 23 October 2026
Sites (10)
- AZ, Tucson, Arizona, United States (recruiting)
- FL, Miami, Florida, United States (recruiting)
- FL, Orlando, Florida, United States (recruiting)
- IL, Chicago, Illinois, United States (recruiting)
- MN, Eden Prairie, Minnesota, United States (recruiting)
- NE, Lincoln, Nebraska, United States (recruiting)
- NV, Las Vegas, Nevada, United States (recruiting)
- NY, New York, New York, United States (recruiting)
- NY, The Bronx, New York, United States (recruiting)
- BC, North Vancouver, British Columbia, Canada (recruiting)
How joining a trial works
- Free to take part
- Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
- Screened first
- Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
- Eligibility is strict
- Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
- You may get a placebo
- Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
- Contact the study team through the registry
- Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
- Not medical advice
- This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.
Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials