The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

NCT05312151 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: COMP 201
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 3

Brief Summary

The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

Conditions

Post Traumatic Stress Disorder

Keywords

psilocybin; COMP360; COMPASS; PTSD; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  A TEAE is defined as an adverse event (AE) that has an onset on or after the dose of study drug, or any pre-existing AE condition that has worsened on or after the dose of study drug.

  Up to 12 weeks

Secondary Outcomes (4)

• Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline

  Week 12

• Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders

  Week 12

• Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.

  Week 12

• Change in Sheehan Disability Scale (SDS) Total Score From Baseline

  Week 12

Study Arms (1)

COMP360 Psilocybin

EXPERIMENTAL

25 mg COMP360 Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Open label

Also known as: COMP360

COMP360 Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood measured via the PCL-5 in combination with the LEC-5 at screening
• Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood as assessed by the CAPS, with a minimum score of 25 at baseline
• Able to identify a next of kin who is willing and able to be reached by the investigators in case of emergency
• Have successfully discontinued all prohibited medications at least two weeks prior to baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of run-in will be required prior to baseline

You may not qualify if:

• Current or past history of schizophrenia, schizoaffective disorder or any other form of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar disorder, or any other significant disorder as assessed by clinician judgement and a structured clinical interview (MINI 7.0.2)
• Diagnosis of complex PTSD according to clinician judgement
• Borderline Personality Disorder as demonstrated by both the McLean Screening Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical confirmation of diagnosis by the study clinician and Medical Monitor
• Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during screening or at baseline, or; (2) suicidal behaviours within the past year, or; (3) history of serious suicide attempt that required a rescuing medical intervention, or; (4) clinical assessment of significant suicidal risk during participant interview
• Current (within the last year) alcohol or substance use disorder as informed by DSM-5 assessed via the MINI 7.0.2 at screening
• Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
• Exposure to 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), or peyote in the past year
• Primary diagnosis of major depressive disorder within 6 months of study entry
• Exposure to a traumatic experience in the past 3 months
• Significant childhood physical or sexual abuse based on clinician judgment with the use of CTQ
• Enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 21 days of baseline

Sponsors & Collaborators

• COMPASS Pathways: lead

Study Sites (3)

Sunstone Therapies

Rockville, Maryland, 20850, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Kings College London, Institute of Psychiatry, Psychology and Neurology

London, United Kingdom

Location

Related Publications (2)

• Modlin NL, Williamson V, Goodwin GM, Malievskaia E, Atli M, Elek Z, Gaillard A, Koelpin D, Cleare A, Agrawal M, Yehuda R, Kirlic N, Rucker J. Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. EClinicalMedicine. 2025 Dec 5;90:103692. doi: 10.1016/j.eclinm.2025.103692. eCollection 2025 Dec.

  PMID: 41497513 DERIVED

• McGowan NM, Rucker JJ, Yehuda R, Agrawal M, Modlin NL, Simmons H, Tofil-Kaluza A, Das S, Goodwin GM. Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. J Psychopharmacol. 2025 Aug 29:2698811251362390. doi: 10.1177/02698811251362390. Online ahead of print.

  PMID: 40883964 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Compass Pathways

info@compasspathways.com

07443136539

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: June 10, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

GB (1); US (2)