A Phase 2/3 interventional study of COMP360 psilocybin in PTSD - Post Traumatic Stress Disorder, PTSD and PTSD Symptoms, sponsored by COMPASS Pathways. Recruiting at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by COMPASS Pathways · Phase 2/3, Interventional, and Treatment
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.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →COMPASS Pathways is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
Drug: COMP360 psilocybin
Drug: COMP360 psilocybin
Drug: COMP360 psilocybin
COMP360 psilocybin administered with monitoring and support
COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score
The CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) is a 30-item structured interview that yields a total severity score (0-80) reflecting PTSD symptoms. A higher CAPS-5 score indicates more severe, intense, and frequent PTSD symptoms.
Time frame: 8 weeks
Started Sep 2026 (actual). Primary completion is estimated for Nov 2028, 26 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Psilocybin
COMPASS Pathways