NCT07570654

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
37mo left

Started Sep 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

PTSD, Post Traumatic Stress DisorderPTSDPTSD Symptoms

Keywords

COMP360psilocybinRedefinePTSDtrauma

Outcome Measures

Primary Outcomes (1)

  • COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score

    8 weeks

Study Arms (3)

1 mg COMP360 psilocybin

ACTIVE COMPARATOR
Drug: COMP360 psilocybin

10 mg COMP360 psilocybin

EXPERIMENTAL
Drug: COMP360 psilocybin

25 mg COMP360 psilocybin

EXPERIMENTAL
Drug: COMP360 psilocybin

Interventions

COMP360 psilocybinDRUG

COMP360 psilocybin administered with monitoring and support

1 mg COMP360 psilocybin10 mg COMP360 psilocybin25 mg COMP360 psilocybin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are 18 years or older
  • Were diagnosed with PTSD at least 6 months ago

You may not qualify if:

  • \- Have been diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04