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

Phase 3RecruitingNCT07570654

COMPASS Pathways300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Florida

Orlando, Florida, United States

RECRUITING

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: 8 weeks