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

Phase 2

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Psilocybin

• Registration Number: NCT05312151
• Lead Sponsor: COMPASS Pathways

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Study Start: 2022-06-10
• Primary Completion: 2023-12-19
• Study Completion: 2024-02-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 the International Trauma Questionnaire (ITQ)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COMP360 Psilocybin	Psilocybin	25 mg COMP360 Psilocybin

Primary Outcome Measures

Name	Time	Method
Safety	Up to 12 weeks	Proportion of patients with adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline	Up to 12 weeks	CAPS-5 is a 30 item scale, each item is scored from 0-4; Higher scores denote greater severity for each item
Change in PTSD checklist for DSM-5 (PCL-5) from baseline	Up to 12 weeks	PCL-5 is a 20-item self-reported scale, each item is scored from 0-4; Higher scores denote greater severity for each item
Change in Sheehan Disability Scale (SDS) total score from baseline	Up to 12 weeks	SDS is a 5-item scale, the total score is from 0 to 30; Higher scores denote greater impairment of function

Trial Locations

Locations (3)

Sunstone Therapies; 🇺🇸 Rockville, Maryland, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Kings College London, Institute of Psychiatry, Psychology and Neurology; 🇬🇧 London, United Kingdom