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 |
|
|
|
Experimental 10 mg COMP360 psilocybin |
|
|
|
Experimental 25 mg COMP360 psilocybin |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- COMPASS Pathways
