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The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05220410
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
COMPASS Pathways
Information provided by (Responsible Party):
Scott T. Aaronson, M.D, Sheppard Pratt Health System

Tracking Information
First Submitted Date  ICMJE January 21, 2022
First Posted Date  ICMJE February 2, 2022
Last Update Posted Date February 8, 2022
Estimated Study Start Date  ICMJE February 4, 2022
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2022)
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: All Visits - Baseline (Day -1 [V2]) to Week 12 (V10) ]
The C-SSRS is a semi-structured interview designed to assess the severity and intensity of suicidal ideation, suicidal behavior, and non-suicidal self injurious behavior over a specified time period. The measurement of suicidal ideation is based on five "yes" or "no" questions with accompanying descriptions arranged in order of increasing severity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2022)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10) ]
    The MADRS is a clinician rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity.
  • Clinical Global Impression - Modified for Depression (CGI-D) [ Time Frame: Baseline (V2) to Week 3 (V7) and Week 12 (V10) ]
    The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
  • Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI) [ Time Frame: Baseline (V2) to Week 3 (V7), and Week 12 (V10) ]
    The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
  • Concise Health Risk Tracking Self Report 12 Items (CHRT-SR) [ Time Frame: Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10) ]
    The CHRT-SR is a 12-item self-report measure that systematically assesses both suicidal thinking and associated thoughts that might indicate the propensity for suicidal acts.
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 Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Official Title  ICMJE The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Brief Summary This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
Detailed Description Not Provided
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
  • Treatment Resistant Depression
  • Suicidal Ideation
Intervention  ICMJE Drug: Psilocybin
Open-Label
Study Arms  ICMJE Experimental: Psilocybin
25mg of 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: January 21, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 18 and 65 years of age at Screening
  • Diagnosis of Major Depressive Disorder (MDD)
  • Significant level of suicidal thoughts with active ideation and without immediate intent
  • Failure to respond to 2 medications in the current episode

Exclusion Criteria:

  • Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
  • Current alcohol or substance use disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sam Rudow (410) 938-3126 srudow@sheppardpratt.org
Contact: Audrey Shoultz (410) 938-5263 audrey.shoultz@sheppardpratt.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05220410
Other Study ID Numbers  ICMJE 49348
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: No
Current Responsible Party Scott T. Aaronson, M.D, Sheppard Pratt Health System
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheppard Pratt Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE COMPASS Pathways
Investigators  ICMJE
Principal Investigator: Scott Aaronson, MD Sheppard Pratt Health System
PRS Account Sheppard Pratt Health System
Verification Date February 2022

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