The Safety and Tolerability of COMP360 in... — Clinical Trial Details

Open-label single-group Phase II trial evaluating safety and tolerability of a single 25 mg oral COMP360 psilocybin dose in adults with PTSD, administered with psychological support.

Key outcomes include adverse events, vital signs, and clinician-rated PTSD severity (CAPS) with assessments at baseline and follow-up; participants must discontinue prohibited medications and meet CAPS and PCL-5 thresholds at baseline.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

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

Exclusion Criteria

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

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial

Integration

Therapeutic Protocol

Study Arms & Interventions

COMP360 Psilocybin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators

Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment