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

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

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorCOMPASS Pathways

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Diagnosed with PTSD at least 6 months ago

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

COMP360 psilocybin
Drug
COMP360 psilocybin administered with monitoring and support

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: 1 mg COMP360 psilocybinActive comparator 1 intervention

Group B: 10 mg COMP360 psilocybinExperimental treatment 1 intervention

Group C: 25 mg COMP360 psilocybinExperimental treatment 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

COMPASS Pathways

Lead sponsor

Source ClinicalTrials.gov

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