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

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ClinicalTrials.gov Identifier: NCT05312151
Recruitment Status : Recruiting
First Posted : April 5, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

Tracking Information
First Submitted Date  ICMJE March 28, 2022
First Posted Date  ICMJE April 5, 2022
Last Update Posted Date May 20, 2022
Estimated Study Start Date  ICMJE June 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2022)
Safety [ Time Frame: Up to 12 weeks ]
Proportion of patients with adverse events (AEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Traumatic Stress Disorder
Intervention  ICMJE Drug: Psilocybin
Open label
Other Name: COMP360
Study Arms  ICMJE Experimental: COMP360 Psilocybin
25 mg COMP360 Psilocybin
Intervention: Drug: Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Director, MD ClinicalOperations@compasspathways.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05312151
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party COMPASS Pathways
Original Responsible Party Same as current
Current Study Sponsor  ICMJE COMPASS Pathways
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account COMPASS Pathways
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP