Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
NCT ID: NCT05624268
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
255 participants
INTERVENTIONAL
2023-01-19
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Overall, 255 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo.
The study comprises three parts (A, B, and C) and will last approximately 62 weeks including a three- to ten-week Screening Period.
Part A will include a six-week follow-up from initial investigational product (IP) administration.
In this study, the primary aim is to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support. This will be assessed in a 6-week, single-dose, double-blind, placebo-controlled part of the study (Part A). Durability of efficacy and long-term safety, and the efficacy and safety of re-treatment will be assessed in a 20-week single-dose, double-blind re-treatment part (Part B), and a 26-week open-label treatment part (Part C).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
Psilocybin
COMP360 Psilocybin administered under supportive conditions
Placebo
Matched placebo
Psilocybin
COMP360 Psilocybin administered under supportive conditions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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. 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. MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
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. At Screening, agreement to discontinue all prohibited medications.
Exclusion Criteria
2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
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. Psychiatric inpatient within the past 12 months prior to Screening
6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
7. Transcranial magnetic stimulation within the past six months prior to Screening
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. Exposure to COMP360 psilocybin therapy prior to Screening
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
COMPASS Pathways
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona College of Medicine - Tuscon
Tucson, Arizona, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Kadima Neuropsychiatry Institute
La Jolla, California, United States
University California San Diego
La Jolla, California, United States
California Center for Psychedelic Therapy
Los Angeles, California, United States
CalNeuro Research Group, Inc
Los Angeles, California, United States
Clarity Clinical Research, LLC
Los Angeles, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Lumos Clinical Research Center
San Jose, California, United States
Stanford University
Stanford, California, United States
ASCLEPES Research Centers
Thousand Oaks, California, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida, United States
APG Research, LLC
Orlando, Florida, United States
DMI Health Care Group, Inc
Tampa, Florida, United States
Meridien Research/Accel Research
Tampa, Florida, United States
Psych Atlanta
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Sheppard Pratt Health System
Baltimore, Maryland, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Pharmasite Research, Inc
Pikesville, Maryland, United States
University of Massachusetts Medical School
North Worcester, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Midwest Research Group
Saint Charles, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Alivation Research, LLC.
Lincoln, Nebraska, United States
Bio Behavioral Health
Toms River, New Jersey, United States
New York State Psychiatric Institute
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Insight Clinical Trials, LLC
Beachwood, Ohio, United States
Neuro-Behaviroral Clinical Research, Inc.
North Canton, Ohio, United States
Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Global Medical Institutes, LLC, Scranton Medical Institute
Moosic, Pennsylvania, United States
UT Health Science Center at Houston (UTHSC-H)
Houston, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Core Clinical Research
Everett, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COMP 005
Identifier Type: -
Identifier Source: org_study_id