Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD
- Registration Number
- NCT05624268
- Lead Sponsor
- COMPASS Pathways
- Brief Summary
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)
- Detailed Description
This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD.
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 255
- Aged ≥18 years at Screening
- Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
- 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
- MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severity of depression
- 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.
- At Screening, agreement to discontinue all prohibited medications.
Key
Psychiatric Exclusion Criteria:
- 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)
- Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement
- Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module
- 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)
- Psychiatric inpatient within the past 12 months prior to Screening
- Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode
- Transcranial magnetic stimulation within the past six months prior to Screening
- 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
- Exposure to COMP360 psilocybin therapy prior to Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 25 mg COMP360 Psilocybin Psilocybin 25 mg COMP360 Psilocybin Placebo Psilocybin Matched placebo
- Primary Outcome Measures
Name Time Method COMP360 25 mg versus placebo for the change from baseline in MADRS total score Week 6 Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
- Secondary Outcome Measures
Name Time Method COMP360 25 mg versus placebo for the change from baseline in SDS total score Week 6 Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
Trial Locations
- Locations (40)
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
🇺🇸Saint 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