Clinical trial NCT05711940: Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Treatment Resistant Depression
Keywords: psilocybin
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 nine-week follow-up from initial investigational product (IP) administration.

Part B will include a further 17 weeks follow-up out to 26 weeks from initial IP administration.

Part C will include a further 26 weeks follow-up out to 52 weeks from initial 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.

Eligibility criteria: Key Inclusion Criteria:

1. Aged ≥18 years at Screening
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

Key Exclusion Criteria:

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. 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

Primary outcomes:
measure: COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.
timeFrame: Week 6
Secondary outcomes:
measure: COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
timeFrame: Week 6
measure: COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.
timeFrame: Week 6
measure: COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.
timeFrame: Week 6
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Riverside
country: United States
facility: CITrials
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group, LLC
state: California
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Behavioral Clinical Research, Inc.
state: Florida
city: Okeechobee
country: United States
facility: Health Synergy Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
state: Florida
city: Tampa
country: United States
facility: University South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Health Synergy Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute PC
state: Michigan
city: Ann Arbor
country: United States
facility: University Of Michigan Comprehensive Depression Center
state: Michigan
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: New York
country: United States
facility: Fieve Clinical Research, Inc
state: New York
city: New York
country: United States
facility: Spectrum Neuroscience and Treatment Institute
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Lutheran Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Austin
country: United States
facility: The University of Texas at Austin - Dell Medical School
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: Dallas
country: United States
facility: Center for Depression Research and Clinical Care
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Houston
country: United States
facility: Brain Health Consultants and TMS Center
state: Texas
city: Plano
country: United States
facility: HCA Healthcare Research Institute - Medical City Green Oaks Hospital
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: The University of Utah - Huntsman Mental Health Institute
state: Utah
city: Seattle
country: United States
facility: Seattle Neuropsychiatric Treatment Center
state: Washington
city: Québec
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: B.C.
city: Kamloops
country: Canada
facility: Medical Arts Health Research Centre, Kamloops
state: British Columbia
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Penticton
country: Canada
facility: Medical Arts Research Group - Penticton
state: British Columbia
city: Chatham
country: Canada
facility: Chatham-Kent Clnical Trials Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
city: Vancouver
country: Canada
facility: Centre for Neurology Studies
city: Vancouver
country: Canada
facility: Medical Arts Research Group
city: Klecany
country: Czechia
facility: National Institute of Mental Health
city: Kutná Hora
country: Czechia
facility: Neuroterapie KH Sro
city: Ostrava
country: Czechia
facility: Psychiatric Ambulance
city: Plzen
country: Czechia
facility: A-Shine s.r.o.
city: Praha
country: Czechia
facility: Psychedelicka klinika, s.r.o.
city: Praha
country: Czechia
facility: Institut Neuropsychiatricke Pece
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital-Psykiatrien Region Nordjylland
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
city: Paris
country: France
facility: Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593)
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)
city: Paris
country: France
facility: Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie
city: Luebeck
country: Germany
facility: ZiP Campus Luebeck
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: La Nua Day Hospital Mental Health Centre
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht (UMC Utrecht)
city: Bydgoszcz
country: Poland
facility: Promente - Ośrodek Badań Klinicznych
city: Gdańsk
country: Poland
facility: Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
city: Poznań
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
city: Suchy Las
country: Poland
facility: Praktyka Lekarska Agnieszka Remlinger-Molenda
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Sant Boi De Llobregat
country: Spain
facility: FIDMAG Hermanas Hospitalarias
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega de Valladolid
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora - Servicio de Psiquiatria
city: Landskrona
country: Sweden
facility: Vuxenpsykiatrimottagningen
city: Lund
country: Sweden
facility: Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
city: Solna
country: Sweden
facility: ClinSmart Sweden AB
city: Stockholm
country: Sweden
facility: ProbarE
city: Bodmin
country: United Kingdom
facility: Cornwall Partnership NHS Foundation Trust
state: Cornwall
city: Edinburgh
country: United Kingdom
facility: Royal Edinburgh Hospital - NHS Lothian
state: Scotland
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital (The Sackler Clinical Research Facility) - Greater Glasgow Health Board
state: Scotland
city: Chertsey
country: United Kingdom
facility: Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust
city: Chester
country: United Kingdom
facility: St. Pancras Clinical Research
city: Doncaster
country: United Kingdom
facility: Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Clinical Research Facility, Royal Devon and Exeter Hospital
city: Fulbourn
country: United Kingdom
facility: Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Pancras Clinical Research
city: London
country: United Kingdom
facility: King's College London - Institute of Psychiatry, Psychology
city: London
country: United Kingdom
facility: Clerkenwell Health
city: Newcastle
country: United Kingdom
facility: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre
city: Nottingham
country: United Kingdom
facility: University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health
city: Oxford
country: United Kingdom
facility: The Warneford Hospital- NIHR Clinical Research Facility
city: Sheffield
country: United Kingdom
facility: Sheffield Health and Social Care NHS Foundation Trust
Study officials:
References: