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

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.

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Key information

Conditions

PTSD - Post Traumatic Stress Disorder Combat Disorders Mental Disorders PTSD PTSD Symptoms PTSD, Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMP360 psilocybin

Drug

COMP360 psilocybin administered with monitoring and support

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

COMPASS Pathways

Industry

Registry information

Official study title

A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Acronym: Redefine

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: May 6, 2026
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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