ACTIVE_NOT_RECRUITING

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

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Conditions

Treatment Resistant Depressionpsilocybin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Official Title

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Quick Facts

Study Start:2023-02-14
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05711940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged ≥18 years at Screening
  2. 2. Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\])
  3. 3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening
  4. 4. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
  5. 5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ
  6. 6. At Screening, agreement to discontinue all prohibited medications
  1. 1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)
  2. 2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
  3. 3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
  4. 4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2)
  5. 5. Psychiatric inpatient within the past 12 months prior to Screening
  6. 6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
  7. 7. Transcranial magnetic stimulation within the past six months prior to Screening
  8. 8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening
  9. 9. Exposure to COMP360 psilocybin therapy prior to Screening

Contacts and Locations

Study Locations (Sites)

Lighthouse Psychiatry Scottsdale
Gilbert, Arizona, 85234
United States
Clinical Innovations, Inc.
Bellflower, California, 90706
United States
M3 Wake Research
Encino, California, 91316
United States
The Regents of the University of California - San Diego
La Jolla, California, 92037-1337
United States
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
United States
CalNeuro Research Group, Inc
Los Angeles, California, 90025
United States
Catalina Research Institute, LLC
Montclair, California, 91763
United States
Piedmont Hospital Neuroscience Centre
Oakland, California, 94610
United States
ATP Clinical Research, Inc.
Orange, California, 92868
United States
CITrials
Riverside, California, 92506
United States
Lumos Clinical Research Center
San Jose, California, 95124
United States
Syrentis Clinical Research
Santa Ana, California, 92705
United States
Stanford University
Stanford, California, 94305
United States
ASCLEPES Research Centers
Thousand Oaks, California, 93012
United States
Pacific Clinical Research Management Group, LLC
Upland, California, 91786
United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
United States
Central Miami Medical Institute, LLC
Miami, Florida, 33125
United States
Behavioral Clinical Research, Inc.
Miami Lakes, Florida, 33016
United States
Health Synergy Clinical Research
Okeechobee, Florida, 34972
United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, 32801
United States
APG Research, LLC- Advanced Psychiatric Group
Orlando, Florida, 32803
United States
University South Florida
Tampa, Florida, 33613-4788
United States
Stedman Clinical Trials
Tampa, Florida, 33613
United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
iResearch Atlanta
Decatur, Georgia, 30030
United States
Rush University Medical Center
Chicago, Illinois, 60612-3227
United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640
United States
Psychiatric Medicine Associates
Skokie, Illinois, 60076
United States
Harvard Medical School - McLean Hospital
Belmont, Massachusetts, 02478-1064
United States
Adams Clinical - Boston (Copley Clinical)
Boston, Massachusetts, 02116
United States
University of Massachusetts Medical School
North Worcester, Massachusetts, 01655
United States
Adams Clinical - Boston
Watertown, Massachusetts, 02472
United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
United States
University Of Michigan Comprehensive Depression Center
Ann Arbor, Michigan, 48109-2700
United States
Institute for Integrative Therapies
Eden Prairie, Minnesota, 55347
United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
United States
Alivation Research, LLC.
Lincoln, Nebraska, 68526
United States
Hassman Research Institute
Berlin, New Jersey, 08009
United States
Princeton Medical Institute
Princeton, New Jersey, 08540
United States
Bio Behavioral Health
Toms River, New Jersey, 08755
United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226-1727
United States
Fieve Clinical Research, Inc
New York, New York, 10017
United States
Spectrum Neuroscience and Treatment Institute
New York, New York, 10021-4157
United States
Adams Clinical - New York
New York, New York, 10029
United States
New York State Psychiatric Institute
New York, New York, 10032
United States
Richmond Behavioral Associates
Staten Island, New York, 10312
United States
Adams Clinical - New York
The Bronx, New York, 10461
United States
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
Cincinnati, Ohio, 45219
United States
Cleveland Clinic - Lutheran Hospital
Cleveland, Ohio, 44113-3108
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Suburban Research Associates
Media, Pennsylvania, 19063
United States
The University of Texas at Austin - Dell Medical School
Austin, Texas, 78712
United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
United States
Relaro Medical Trials
Dallas, Texas, 75243
United States
Center for Depression Research and Clinical Care
Dallas, Texas, 75247-9119
United States
North Texas Clinical Trials
Fort Worth, Texas, 76104
United States
Brain Health Consultants and TMS Center
Houston, Texas, 77046-2401
United States
HCA Healthcare Research Institute - Medical City Green Oaks Hospital
Plano, Texas, 75251
United States
Cedar Clinical Research
Draper, Utah, 84020
United States
The University of Utah - Huntsman Mental Health Institute
Salt Lake City, Utah, 84108
United States
Seattle Neuropsychiatric Treatment Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: COMPASS Pathways

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-14
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-02-14
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • psilocybin

Additional Relevant MeSH Terms

  • Treatment Resistant Depression