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

Study Overview
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Brief Summary
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The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

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

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMP360 Psilocybin<br>25 mg COMP360 Psilocybin | Drug: Psilocybin<br>* Open label<br>* Other names: COMP360;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Proportion of patients with adverse events (AEs) | Up to 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psilocybin, COMP360, COMPASS, PTSD, Post Traumatic Stress Disorder