Clinical trial NCT05312151: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Official title: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: psilocybin
COMP360
COMPASS
PTSD
Post Traumatic Stress Disorder
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

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

Primary outcomes:
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline
timeFrame: Week 12
measure: Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders
timeFrame: Week 12
measure: Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.
timeFrame: Week 12
measure: Change in Sheehan Disability Scale (SDS) Total Score From Baseline
timeFrame: Week 12
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sunstone Therapies
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: London
country: United Kingdom
facility: Kings College London, Institute of Psychiatry, Psychology and Neurology
Study officials:
References: