Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
- Registration Number
- NCT05711940
- Lead Sponsor
- COMPASS Pathways
- Brief Summary
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Detailed Description
This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD.
Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg.
The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration.
In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 568
- 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
- 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 10 mg COMP360 Psilocybin Psilocybin 10 mg COMP360 Psilocybin 1 mg COMP360 Psilocybin Psilocybin 1 mg COMP360 Psilocybin, active comparator
- Primary Outcome Measures
Name Time Method COMP360 25 mg versus COMP360 1 mg 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 COMP360 10 mg for the change from baseline in Sheehan Disability Scale (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.
COMP360 25 mg versus COMP360 10 mg 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
COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (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 (95)
Clinical Innovations, Inc.
🇺🇸Bellflower, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
CITrials
🇺🇸Riverside, California, United States
Lumos Clinical Research Center
🇺🇸San Jose, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Pacific Clinical Research Management Group, LLC
🇺🇸Upland, California, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
🇺🇸Miami Lakes, Florida, United States
Health Synergy Clinical Research
🇺🇸Okeechobee, Florida, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
🇺🇸Orlando, Florida, United States
University South Florida
🇺🇸Tampa, Florida, United States
Health Synergy Clinical Research, LLC
🇺🇸West Palm Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta
🇺🇸Decatur, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
University Of Michigan Comprehensive Depression Center
🇺🇸Ann Arbor, Michigan, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Fieve Clinical Research, Inc
🇺🇸New York, New York, United States
Spectrum Neuroscience and Treatment Institute
🇺🇸New York, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic - Lutheran Hospital
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
The University of Texas at Austin - Dell Medical School
🇺🇸Austin, Texas, United States
Houston Clinical Trials, LLC
🇺🇸Bellaire, Texas, United States
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
Center for Depression Research and Clinical Care
🇺🇸Dallas, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Brain Health Consultants and TMS Center
🇺🇸Houston, Texas, United States
HCA Healthcare Research Institute - Medical City Green Oaks Hospital
🇺🇸Plano, Texas, United States
Cedar Clinical Research
🇺🇸Draper, Utah, United States
Medical Arts Research Group
🇨🇦Vancouver, Canada
The University of Utah - Huntsman Mental Health Institute
🇺🇸Salt Lake City, Utah, United States
Seattle Neuropsychiatric Treatment Center
🇺🇸Seattle, Washington, United States
Diex Recherche Sherbrooke Inc.
🇨🇦Québec, B.C., Canada
Medical Arts Health Research Centre, Kamloops
🇨🇦Kamloops, British Columbia, Canada
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Medical Arts Research Group - Penticton
🇨🇦Penticton, British Columbia, Canada
Chatham-Kent Clnical Trials Centre
🇨🇦Chatham, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Centre for Addiction and Mental Health (CAMH)
🇨🇦Toronto, Ontario, Canada
Centre for Neurology Studies
🇨🇦Vancouver, Canada
National Institute of Mental Health
🇨🇿Klecany, Czechia
Neuroterapie KH Sro
🇨🇿Kutná Hora, Czechia
Psychiatric Ambulance
🇨🇿Ostrava, Czechia
A-Shine s.r.o.
🇨🇿Plzen, Czechia
Psychedelicka klinika, s.r.o.
🇨🇿Praha, Czechia
Institut Neuropsychiatricke Pece
🇨🇿Praha, Czechia
Aalborg Universitetshospital-Psykiatrien Region Nordjylland
🇩🇰Aalborg, Denmark
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
🇫🇷Nîmes, France
Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593)
🇫🇷Paris, France
Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)
🇫🇷Paris, France
Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique
🇫🇷Paris, France
Charite-Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie
🇩🇪Frankfurt, Germany
ZiP Campus Luebeck
🇩🇪Luebeck, Germany
Tallaght University Hospital
🇮🇪Dublin, Ireland
La Nua Day Hospital Mental Health Centre
🇮🇪Galway, Ireland
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC)
🇳🇱Leiden, Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht)
🇳🇱Utrecht, Netherlands
Promente - Ośrodek Badań Klinicznych
🇵🇱Bydgoszcz, Poland
Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych
🇵🇱Gdańsk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdańsk, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Poznań, Poland
Praktyka Lekarska Agnieszka Remlinger-Molenda
🇵🇱Suchy Las, Poland
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)
🇪🇸Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
FIDMAG Hermanas Hospitalarias
🇪🇸Sant Boi De Llobregat, Spain
Hospital Universitario Río Hortega de Valladolid
🇪🇸Valladolid, Spain
Hospital Provincial de Zamora - Servicio de Psiquiatria
🇪🇸Zamora, Spain
Vuxenpsykiatrimottagningen
🇸🇪Landskrona, Sweden
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
🇸🇪Lund, Sweden
ClinSmart Sweden AB
🇸🇪Solna, Sweden
ProbarE
🇸🇪Stockholm, Sweden
Cornwall Partnership NHS Foundation Trust
🇬🇧Bodmin, Cornwall, United Kingdom
Royal Edinburgh Hospital - NHS Lothian
🇬🇧Edinburgh, Scotland, United Kingdom
Queen Elizabeth University Hospital (The Sackler Clinical Research Facility) - Greater Glasgow Health Board
🇬🇧Glasgow, Scotland, United Kingdom
Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust
🇬🇧Chertsey, United Kingdom
St. Pancras Clinical Research
🇬🇧London, United Kingdom
Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust
🇬🇧Doncaster, United Kingdom
Clinical Research Facility, Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust
🇬🇧Fulbourn, United Kingdom
King's College London - Institute of Psychiatry, Psychology
🇬🇧London, United Kingdom
Clerkenwell Health
🇬🇧London, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre
🇬🇧Newcastle, United Kingdom
University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health
🇬🇧Nottingham, United Kingdom
The Warneford Hospital- NIHR Clinical Research Facility
🇬🇧Oxford, United Kingdom
Sheffield Health and Social Care NHS Foundation Trust
🇬🇧Sheffield, United Kingdom