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

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

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Psilocybin

Detailed Description

The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Kings College London, Institute of Psychiatry, Psychology and Neurology
• United States
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Sunstone Therapies
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COMP360 Psilocybin; 25 mg COMP360 Psilocybin	Drug: Psilocybin; Open label; Other Names: COMP360

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline	CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity.	Week 12
Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders	CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity. A participant is defined as a responder if they have a greater than or equal to 15 point improvement on the CAPS-5 total severity score compared to Baseline.	Week 12
Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.	CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity. A participant is defined as remitter at any post-baseline timepoint if their CAPS-5 total severity score is less than or equal to 20.	Week 12
Change in Sheehan Disability Scale (SDS) Total Score From Baseline	SDS is a 5 item scale. The total score is calculated by summing the 3 domains (work/school, social life, and family life - each domain has a 0-10 range). The total score has a range from 0 to 30, with 0 representing no impairment and 30 representing severe impairment.	Week 12

Collaborators and Investigators

• Sponsor: COMPASS Pathways

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; psilocybin; Post Traumatic Stress Disorder; COMPASS; COMP360
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• Other Study ID Numbers: COMP 201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No