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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07570654

Acronym

Redefine

Enrollment

300

Registered

2026-05-06

Start date

2026-09-01

Completion date

2029-09-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

COMP360, psilocybin, Redefine, PTSD, trauma

Brief 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.

Interventions

DRUGCOMP360 psilocybin

COMP360 psilocybin administered with monitoring and support

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTRedefine Study Call Center

TheRedefineStudy@compasspathways.com202-459-9258

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026