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

• ClinicalTrials.gov Identifier: NCT05312151
• Recruitment Status: Active, not recruiting
• First Posted: April 5, 2022
• Last Update Posted: April 9, 2024
• Sponsor: COMPASS Pathways
• Information provided by (Responsible Party): COMPASS Pathways

Tracking Information

• First Submitted Date: March 28, 2022
• First Posted Date: April 5, 2022
• Last Update Posted Date: April 9, 2024
• Actual Study Start Date: June 10, 2022
• Actual Primary Completion Date: December 19, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2022)

Safety [ Time Frame: Up to 12 weeks ]

Proportion of patients with adverse events (AEs)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2022)

• Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Post Traumatic Stress Disorder

Intervention

Drug: Psilocybin

Open label

Other Name: COMP360

Study Arms

Experimental: COMP360 Psilocybin

25 mg COMP360 Psilocybin

Intervention: Drug: Psilocybin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 11, 2024): 22
• Original Estimated Enrollment (submitted: March 28, 2022): 20
• Estimated Study Completion Date: April 2024
• Actual Primary Completion Date: December 19, 2023 (Final data collection date for primary outcome measure)

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT05312151
• Other Study ID Numbers: COMP201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: COMPASS Pathways
• Original Responsible Party: Same as current
• Current Study Sponsor: COMPASS Pathways
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: COMPASS Pathways
• Verification Date: April 2024