NCT07570654 Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
| NCT ID | NCT07570654 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | COMPASS Pathways |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-09-14 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2026-09-14 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
www.redefineptsdstudy.com Redefine Study Call Center
✉ TheRedefineStudy@compasspathways.com📞 202-459-9258
Frequently Asked Questions
Who can join the NCT07570654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07570654 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07570654 currently recruiting?
Yes, NCT07570654 is actively recruiting participants. Contact the research team at TheRedefineStudy@compasspathways.com for enrollment information.
Where is the NCT07570654 trial being conducted?
This trial is being conducted at Tucson, United States, Irvine, United States, Los Angeles, United States, Moorpark, United States and 11 additional locations.
Who is sponsoring the NCT07570654 clinical trial?
NCT07570654 is sponsored by COMPASS Pathways. The trial plans to enroll 300 participants.
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