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Clinical Trials in the USA / NCT07570654
Recruiting Phase 2/3

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

NCT07570654 · tracked via the Priya Life Science USA tracker
Sponsor
COMPASS Pathways
Phase
Phase 2/3
Started
2026-09-14
Last updated
2026-11-05

Condition(s) studied

PTSD - Post Traumatic Stress DisorderPTSDPTSD SymptomsPTSD, Post Traumatic Stress Disorder

Investigational drug(s) / intervention(s)

COMP360 psilocybin

COMP360 psilocybin: COMP360 psilocybin administered with monitoring and support

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score — 8 weeks
    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.

Trial sites (17)

FacilityCityRegionStatus
AZ Tucson Arizona Recruiting
CA Irvine California Recruiting
CA Los Angeles California Recruiting
CA Moorpark California Recruiting
FL Miami Florida Recruiting
FL Orlando Florida Recruiting
IL Chicago Illinois Recruiting
MA Boston Massachusetts Recruiting
MN Eden Prairie Minnesota Recruiting
NE Lincoln Nebraska Recruiting
NV Las Vegas Nevada Recruiting
NY New York New York Recruiting
NY The Bronx New York Recruiting
OH North Canton Ohio Recruiting
TX Carrollton Texas Recruiting
BC Kamloops British Columbia Recruiting
BC North Vancouver British Columbia Recruiting

More COMPASS Pathways trials in the USA

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Active, not recruiting
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder Active, not recruiting

Other trials for the same condition

Trifecta Research Study Active, not recruiting
Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder Recruiting
Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD) Recruiting
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool Recruiting
Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07570654 on ClinicalTrials.gov ↗ ← All trials in the USA