Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Redefine
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
1 other identifier
interventional
300
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2026
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
October 1, 2026
April 1, 2026
2.2 years
April 30, 2026
September 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Study Arms (3)
1 mg COMP360 psilocybin
ACTIVE COMPARATOR10 mg COMP360 psilocybin
EXPERIMENTAL25 mg COMP360 psilocybin
EXPERIMENTALInterventions
COMP360 psilocybin administered with monitoring and support
Eligibility Criteria
You may qualify if:
- years or older
- Diagnosed with PTSD at least 6 months ago
You may not qualify if:
- \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- COMPASS Pathwayslead
Study Sites (4)
FL
Miami, Florida, 33125, United States
FL
Orlando, Florida, 32801, United States
NE
Lincoln, Nebraska, 68526, United States
NY
New York, New York, 10025, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2026
First Posted
May 6, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
September 1, 2029
Last Updated
October 1, 2026
Record last verified: 2026-04