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

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NCT07570654 · readout ≤ 834 d

Sponsored by COMPASS Pathways (industry) · CMPS — their whole pipeline →.

Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
300estimated
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
StartSep 2026estimatedWhen the study began enrolling
Primary completionNov 2028estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionSep 2029estimatedThe whole study's end, after follow-up
First posted2026-05-06actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Intervention

  • Drug: COMP360 psilocybin

Primary outcome

what the primary-completion date above is the date OF
COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score
measured 8 weeks

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