NCT07570654Phase 2, phase 3Recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-11Estimated

Enrollment · participants300Estimated

Source updated2026-09-04Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-18 · 1 field changed

Recruitment status changed

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~~Not yet recruiting~~

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Recruiting

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Study details

Conditions studied

PTSD - Post Traumatic Stress Disorder; PTSD; PTSD Symptoms; PTSD, Post Traumatic Stress Disorder

Treatments or interventions studied

COMP360 psilocybinDrug

Primary outcomes · main study measures

measure: COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score; description: 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.; timeFrame: 8 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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