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

Sponsor
COMPASS Pathways
Study ID
NCT07570654
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • COMP360 psilocybin — DRUG
    COMP360 psilocybin administered with monitoring and support

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1 mg COMP360 psilocybin
  • Experimental: 10 mg COMP360 psilocybin
  • Experimental: 25 mg COMP360 psilocybin

Primary Outcome Measure

COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score [ Time Frame: 8 weeks ]

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