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History of Changes for Study: NCT05312151
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Latest version (submitted July 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 28, 2022 None (earliest Version on record)
2 May 18, 2022 Study Status and Contacts/Locations
3 July 20, 2022 Study Status and Contacts/Locations
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Study NCT05312151
Submitted Date:  March 28, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: COMP201
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Recruiting
Study Start: April 2022
Primary Completion: June 2023 [Anticipated]
Study Completion: August 2023 [Anticipated]
First Submitted: March 28, 2022
First Submitted that
Met QC Criteria:
March 28, 2022
First Posted: April 5, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
March 28, 2022
Last Update Posted: April 5, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: COMPASS Pathways
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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
Open or close this module Conditions
Conditions: Post Traumatic Stress Disorder
Keywords: psilocybin
COMP360
COMPASS
PTSD
Post Traumatic Stress Disorder
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: COMP360 Psilocybin
25 mg COMP360 Psilocybin
Drug: Psilocybin
Open label
Other Names:
  • COMP360
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety
[ Time Frame: Up to 12 weeks ]

Proportion of patients with adverse events (AEs)
Secondary Outcome Measures:
1. 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
2. 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
3. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Medical Director, MD
Email: ClinicalOperations@compasspathways.com
Locations: United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology
[Recruiting]
London, United Kingdom
Contact:Contact: James Rucker, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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