Phase
Condition
Depression
Treatment
Psilocybin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Aged ≥18 years at Screening
Major depression without psychotic features (single or recurrent episode as informedby the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])
If the current major depressive episode is the participant's first lifetime episodeof depression, the length of the current episode must be ≥3 months and ≤2 years atScreening
MADRS total score ≥20 at Screening and Baseline to ensure at least moderate severityof 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 determinedthrough the Massachusetts General Hospital Antidepressant Treatment ResponseQuestionnaire (MGH-ATRQ) and using the supplementary advice on additionalantidepressants not included in MGH-ATRQ
At Screening, agreement to discontinue all prohibited medications
Exclusion
Key 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 personalitydisorder as assessed by a structured clinical interview (MINI 7.0.2)
Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personalitydisorder, or any ongoing serious psychiatric comorbidity based on medical historyand clinical judgement
Borderline personality disorder as demonstrated by medical history or the MiniInternational Neuropsychiatric Interview Plus (MINI plus) - borderline personalitydisorder module
Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexianervosa 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 stimulationduring 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 stablefor the duration of the study. Psychological therapies cannot have been initiatedwithin 30 days prior to Screening
Exposure to COMP360 psilocybin therapy prior to Screening
Study Design
Study Description
Connect with a study center
Diex Recherche Sherbrooke Inc.
Québec, B.C. J1L 0H8
CanadaActive - Recruiting
Medical Arts Health Research Centre, Kamloops
Kamloops, British Columbia
CanadaActive - Recruiting
Okanagan Clinical Trials
Kelowna, British Columbia V1Y 1Z9
CanadaActive - Recruiting
Medical Arts Research Group - Penticton
Penticton, British Columbia V2A 5L5
CanadaActive - Recruiting
Chatham-Kent Clnical Trials Centre
Chatham, Ontario
CanadaActive - Recruiting
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
St. Michaels Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Centre for Neurology Studies
Vancouver,
CanadaActive - Recruiting
Medical Arts Research Group
Vancouver,
CanadaActive - Recruiting
National Institute of Mental Health
Klecany, 25067
CzechiaActive - Recruiting
Neuroterapie KH Sro
Kutná Hora, 28401
CzechiaSite Not Available
Psychiatric Ambulance
Ostrava, 70868
CzechiaSite Not Available
A-Shine s.r.o.
Plzen, 30100
CzechiaSite Not Available
Institut Neuropsychiatricke Pece
Praha, 18600
CzechiaActive - Recruiting
Psychedelicka klinika, s.r.o.
Praha, 16300
CzechiaActive - Recruiting
Aalborg Universitetshospital-Psykiatrien Region Nordjylland
Aalborg, 9000
DenmarkActive - Recruiting
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nîmes, 30000
FranceActive - Recruiting
Centre Hospitalier Sainte Anne
Paris, 75014
FranceSite Not Available
Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)
Paris, 75014
FranceActive - Recruiting
Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique
Paris, 75014
FranceActive - Recruiting
Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593)
Paris, 75013
FranceActive - Recruiting
Charite-Universitaetsmedizin Berlin
Berlin, 12203
GermanyActive - Recruiting
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie
Frankfurt, 60528
GermanyActive - Recruiting
ZiP Campus Luebeck
Luebeck, 23562
GermanyActive - Recruiting
Tallaght University Hospital
Dublin, D24 NR0A
IrelandActive - Recruiting
La Nua Day Hospital Mental Health Centre
Galway, H91 VE03
IrelandTerminated
University Medical Center Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC)
Leiden, 2300
NetherlandsActive - Recruiting
Universitair Medisch Centrum Utrecht (UMC Utrecht)
Utrecht, 3584 CG
NetherlandsActive - Recruiting
Promente - Ośrodek Badań Klinicznych
Bydgoszcz, 85-133
PolandActive - Recruiting
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdańsk, 80-546
PolandActive - Recruiting
Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych
Gdańsk, 80-214
PolandActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)
Barcelona, 08830
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
FIDMAG Hermanas Hospitalarias
Sant Boi De Llobregat, 08830
SpainActive - Recruiting
Hospital Universitario Río Hortega de Valladolid
Valladolid, 47012
SpainActive - Recruiting
Hospital Provincial de Zamora - Servicio de Psiquiatria
Zamora, 49021
SpainActive - Recruiting
Vuxenpsykiatrimottagningen
Landskrona, 26153
SwedenActive - Recruiting
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
Lund, 22185
SwedenActive - Recruiting
ClinSmart Sweden AB
Solna, 17164
SwedenActive - Recruiting
ProbarE
Stockholm, 11239
SwedenActive - Recruiting
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall PL31 2QT
United KingdomActive - Recruiting
Royal Edinburgh Hospital - NHS Lothian
Edinburgh, Scotland EH10 5HF
United KingdomSite Not Available
Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 9AU
United KingdomActive - Recruiting
Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust
Doncaster, DN4 8QN
United KingdomActive - Recruiting
Clinical Research Facility, Royal Devon and Exeter Hospital
Exeter, EX2 5DW
United KingdomActive - Recruiting
Clerkenwell Health
London, W1G 8DR
United KingdomActive - Recruiting
King's College London - Institute of Psychiatry, Psychology
London, SE5 8AF
United KingdomActive - Recruiting
St. Pancras Clinical Research
London, EC2Y 8EA
United KingdomActive - Recruiting
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre
Newcastle, NE4 5PL
United KingdomActive - Recruiting
University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health
Nottingham, NG7 2TU
United KingdomActive - Recruiting
The Warneford Hospital- NIHR Clinical Research Facility
Oxford, OX3 7JX
United KingdomActive - Recruiting
Cornwall Partnership NHS Foundation Trust and SW Peninsula Clinical Research Network
Saltash, PL12 5LN
United KingdomSite Not Available
Sheffield Health and Social Care NHS Foundation Trust
Sheffield, S10 3TH
United KingdomActive - Recruiting
Clinical Innovations, Inc.
Bellflower, California 90706
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair, California 91763
United StatesActive - Recruiting
CITrials
Riverside, California 92506
United StatesTerminated
Lumos Clinical Research Center
San Jose, California 95124
United StatesActive - Recruiting
Syrentis Clinical Research
Santa Ana, California 92705
United StatesActive - Recruiting
Pacific Clinical Research Management Group, LLC
Upland, California 91786
United StatesActive - Recruiting
Innovative Clinical Research, Inc.
Lauderhill, Florida 33319
United StatesActive - Recruiting
Behavioral Clinical Research, Inc.
Miami Lakes, Florida 33016
United StatesTerminated
Health Synergy Clinical Research
Okeechobee, Florida 34972
United StatesActive - Recruiting
APG Research, LLC
Orlando, Florida 32803
United StatesActive - Recruiting
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare
Orlando, Florida 32801
United StatesSite Not Available
University South Florida
Tampa, Florida 33613-4788
United StatesActive - Recruiting
Atlanta Behavioral Research
Atlanta, Georgia 30338
United StatesActive - Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesTerminated
iResearch Atlanta
Decatur, Georgia 30030
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612-3227
United StatesActive - Recruiting
Michigan Clinical Research Institute PC
Ann Arbor, Michigan 48105
United StatesActive - Recruiting
University Of Michigan Comprehensive Depression Center
Ann Arbor, Michigan 48109-2700
United StatesActive - Recruiting
Hassman Research Institute
Berlin, New Jersey 08009
United StatesActive - Recruiting
Princeton Medical Institute
Princeton, New Jersey 08540
United StatesActive - Recruiting
Fieve Clinical Research, Inc
New York, New York 10017
United StatesActive - Recruiting
Spectrum Neuroscience and Treatment Institute
New York, New York 10021-4157
United StatesActive - Recruiting
Richmond Behavioral Associates
Staten Island, New York 10312
United StatesTerminated
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic - Lutheran Hospital
Cleveland, Ohio 44113-3108
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Suburban Research Associates
Media, Pennsylvania 19063
United StatesActive - Recruiting
The University of Texas at Austin - Dell Medical School
Austin, Texas 78712
United StatesActive - Recruiting
Houston Clinical Trials, LLC
Bellaire, Texas 77401
United StatesActive - Recruiting
Center for Depression Research and Clinical Care
Dallas, Texas 75247-9119
United StatesActive - Recruiting
Relaro Medical Trials
Dallas, Texas 75243
United StatesActive - Recruiting
North Texas Clinical Trials
Fort Worth, Texas 76104
United StatesActive - Recruiting
Brain Health Consultants and TMS Center
Houston, Texas 77046-2401
United StatesActive - Recruiting
HCA Healthcare Research Institute - Medical City Green Oaks Hospital
Plano, Texas 75251
United StatesActive - Recruiting
The University of Utah - Huntsman Mental Health Institute
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Seattle Neuropsychiatric Treatment Center
Seattle, Washington 98104
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.