Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts 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

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator 1 mg COMP360 psilocybin		Drug: COMP360 psilocybin COMP360 psilocybin administered with monitoring and support
Experimental 10 mg COMP360 psilocybin		Drug: COMP360 psilocybin COMP360 psilocybin administered with monitoring and support
Experimental 25 mg COMP360 psilocybin		Drug: COMP360 psilocybin COMP360 psilocybin administered with monitoring and support

Recruiting Locations

More Details

Status: Recruiting
Sponsor: COMPASS Pathways

Study Contact

Redefine Study Call Center
202-459-9258
TheRedefineStudy@compasspathways.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.