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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 : June 13, 2023
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

Study Description
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Brief Summary:
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Psilocybin Phase 2

Detailed Description:
The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Actual Study Start Date : June 10, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: COMP360 Psilocybin
25 mg COMP360 Psilocybin
 Drug: Psilocybin
Open label
Other Name: COMP360


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05312151


Contacts
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Contact: Medical Director, MD info@compasspathways.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Carolyn Macleod    646-438-5044    carolyn.macleod@va.gov   
Principal Investigator: Rachel Yehuda, MD         
United Kingdom
Kings College London, Institute of Psychiatry, Psychology and Neurology Recruiting
London, United Kingdom
Contact: James Rucker, MD       COMP201@kcl.ac.uk   
Sponsors and Collaborators
COMPASS Pathways
More Information
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Responsible Party: COMPASS Pathways
ClinicalTrials.gov Identifier: NCT05312151    
Other Study ID Numbers: COMP201
First Posted: April 5, 2022    Key Record Dates
Last Update Posted: June 13, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by COMPASS Pathways:
psilocybin
COMP360
COMPASS
PTSD
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
 Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs