Recruiting
Phase 2
Phase 3

COMP360

Sponsor:

COMPASS Pathways

Code:

NCT07570654

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD

PTSD Symptoms

PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COMP360 psilocybin

Study Details

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.

Conditions

PTSD - Post Traumatic Stress Disorder

PTSD

PTSD Symptoms

PTSD, Post Traumatic Stress Disorder

Study ID

NCT07570654

Start date

Sep, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1 mg COMP360 psilocybin

experimental: 10 mg COMP360 psilocybin

experimental: 25 mg COMP360 psilocybin

Interventions

COMP360 psilocybin

COMP360 psilocybin administered with monitoring and support

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 ]

Central Contacts and Locations

Central contacts

www.redefineptsdstudy.com Redefine Study Call Center

202-459-9258TheRedefineStudy@compasspathways.com

Locations

AZ

Recruiting

Tucson, Arizona, United States, 85704

FL

Recruiting

Miami, Florida, United States, 33125

FL

Recruiting

Orlando, Florida, United States, 32801

IL

Recruiting

Chicago, Illinois, United States, 60612

MN

Recruiting

Eden Prairie, Minnesota, United States, 55347

NE

Recruiting

Lincoln, Nebraska, United States, 68526

NV

Recruiting

Las Vegas, Nevada, United States, 89119

NY

Recruiting

New York, New York, United States, 10025

NY

Recruiting

The Bronx, New York, United States, 10461

BC

Recruiting

North Vancouver, British Columbia, Canada, V7P2T4

More Information

Sponsor

COMPASS Pathways

Last update posted

Oct 23, 2026

Last verified

Apr, 2026

Keywords

  • COMP360
  • psilocybin
  • Redefine
  • PTSD
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by COMPASS Pathways on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.