Phase
Condition
Depression
Treatment
Placebo
Aticaprant
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be medically stable on the basis of physical examination, medical history, vitalsigns, and 12-lead electrocardiogram (ECG) performed at screening and baseline
Have a Hamilton depression rating Scale 17 item (HDRS-17) total score of 20 orhigher at the first and second screening interviews and must not demonstrate aclinically significant improvement (that is, an improvement of more than 20 percent [%] on their HDRS-17 total score) between the first and the second independentHDRS-17 assessments
Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5)diagnostic criteria for recurrent or single episode major depressive disorder (MDD),without psychotic features, based upon clinical assessment and confirmed by thestructural interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT).Participants 65 years of age or older must have had the first onset of depressionprior to 55 years of age
Is currently receiving and tolerating well any one of the following selectiveserotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation andavailable in the participating country/territory: citalopram, duloxetine,escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine,sertraline, venlafaxine, desvenlafaxine at a stable dose (at or above the minimumtherapeutic dose per Massachusetts General Hospital Antidepressant TreatmentResponse Questionnaire [MGH-ATRQ] for at least 6 weeks. The current antidepressantcannot be the first antidepressant treatment for the first lifetime episode ofdepression
Participant's current major depressive episode, and antidepressant treatmentresponse in the current depressive episode, must all be confirmed by the SiteIndependent Qualification Assessment
Exclusion
Exclusion Criteria:
Have had in the current depressive episode, no response (treatment failure) to 5 ormore antidepressant treatments including the current SSRI/SNRI (that is, the onepresumed to be continued in the treatment phase) assessed using the MGH-ATRQ
Has a history or evidence of clinically meaningful noncompliance with currentantidepressant therapy
Has a history of moderate-to-severe substance use disorder including alcohol usedisorder according to diagnostic and statistical manual of mental disorders-5thedition (DSM-5) criteria within 6 months before screening
Has had in the current episode an inadequate response to adequate course ofintravenous or intranasal ketamine or esketamine, electroconvulsive therapy (thatis, at least 7 treatments), vagal nerve stimulation, or deep brain stimulationdevice
Has current, or a history (past 6 months), of seizures
Has a current homicidal ideation/intent, per the investigator's clinical judgment,or has suicidal ideation with some intent to act within 3 months prior to the startof the Screening Phase, per the investigator's clinical judgment or based on theColumbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specificplan) or Item 5 (active suicidal ideation with specific plan and intent), or ahistory of suicidal behavior within the past 6 months prior to the start of theScreening Phase. Participants reporting suicidal ideation with intent to act orsuicidal behavior at baseline should be excluded
Has one or more of the following diagnoses: a) A diagnostic and statistical manualof mental disorders-5th edition (DSM-5) diagnosis (which has been the primary focusof psychiatric treatment within the past 2 years) of any of the following: panicdisorder, generalized anxiety disorder social anxiety disorder, specific phobia; b)A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c)A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or majordepressive disorder (MDD) with psychotic features, bipolar or related disorders,intellectual disability, autism spectrum disorder, borderline personality disorder,antisocial personality disorder, histrionic personality disorder, narcissisticpersonality disorders, somatoform disorders
Study Design
Study Description
Connect with a study center
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaSite Not Available
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaSite Not Available
CEN Consultorios Especializados en Neurociencias
Cordoba, 5000FJF
ArgentinaSite Not Available
CEN-Consultorios Especializados en Neurociencias
Cordoba, 5000FJF
ArgentinaActive - Recruiting
Centro Medico Luquez
Cordoba, X5006IKK
ArgentinaSite Not Available
Instituto Medico DAMIC
Cordoba, X5003DCE
ArgentinaSite Not Available
Clinica Privada de Salud Mental Santa Teresa de Ávila
La Plata, Thanks
ArgentinaSite Not Available
INSA Instituto de Neurociencias San Agustín
La Plata, 1900
ArgentinaSite Not Available
C I A P Centro de investigacion y Asistencia en Psiquiatria
Rosario, 2000
ArgentinaSite Not Available
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
Rosario, 2000
ArgentinaSite Not Available
Clinica Mayo de UMCB
San Miguel de Tucuman, 4000
ArgentinaSite Not Available
Clinica El Jardin
Santiago del Estero, 4200
ArgentinaSite Not Available
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100
BrazilSite Not Available
L2IP - Instituto de Pesquisas Clínicas
Brasilia, 70200-730
BrazilSite Not Available
L2IP - Instituto de Pesquisas Clínicas
Brasília, 70200-730
BrazilSite Not Available
Trial Tech Tecnologia em Pesquisas com Medicamentos
Curitiba, 80240-280
BrazilSite Not Available
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilSite Not Available
Associação Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilSite Not Available
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09715-090
BrazilSite Not Available
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
BulgariaSite Not Available
MHC - Sofia, EOOD
Sofia, 1202
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
Medical Center Intermedica, OOD
Sofia, 1680
BulgariaSite Not Available
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
BulgariaSite Not Available
Okanagan Clinical Trials
Kelowna, British Columbia V1Y 1Z9
CanadaSite Not Available
The University of British Columbia
Vancouver, British Columbia V6T 2B5
CanadaSite Not Available
True North Clinical Research Halifax - D.B.A Centricity Research Halifax
New Minas, Nova Scotia B4N 3R7
CanadaSite Not Available
Queen's University
Kingston, Ontario K7L 3N6
CanadaSite Not Available
University of Ottawa Institute of Mental Health Research
Ottawa, Ontario K1Z 7K4
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
DIEX Recherche Sherbrooke Inc
Sherbrooke, Quebec J1L 0H8
CanadaSite Not Available
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec J1L 0H8
CanadaActive - Recruiting
Alpha Recherche Clinique
Quebec, G2J 0C4
CanadaSite Not Available
Hebei Mental Health Center
Baoding, 071000
ChinaSite Not Available
Beijing Anding Hospital of Capital Medical University
Beijing, 100088
ChinaSite Not Available
Beijing Huilongguan Hospital
Beijing, 100096
ChinaSite Not Available
Peking University Sixth Hospital
Beijing, 100191
ChinaSite Not Available
The second Xiangya Hospital of Central South University
Changsha, 410011
ChinaSite Not Available
West China Hospital Sichuan University
Chengdu, 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaSite Not Available
Chongqing Mental Health Center
Chongqing, 401147
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510060
ChinaSite Not Available
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, 310009
ChinaSite Not Available
Huzhou third people's Hospital
Hu Zhou, 313000
ChinaSite Not Available
Shanghai Mental Health Center
Shanghai, 200030
ChinaSite Not Available
Tongji Hospital of Tongji University
Shanghai, 200065
ChinaSite Not Available
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
ChinaSite Not Available
Suzhou Guangji Hospital
Suzhou, 215003
ChinaSite Not Available
Tianjin Anding Hospital
Tianjin, 300222
ChinaSite Not Available
Wuhan Mental Health Center
Wuhan, 430000
ChinaSite Not Available
Wuhu Hospital of Beijing Anding hospital
Wuhu, 242407
ChinaSite Not Available
XiAn Mental Healthcare Center
XI An, 710061
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zheng Zhou, 450052
ChinaSite Not Available
Psychiatricka ambulance Saint Anne s.r.o.
Brno, 60200
CzechiaSite Not Available
Psychiatricka ambulance, MUDr. Marta Holanova
Brno, 61500
CzechiaSite Not Available
Neuroterapie KH S R O
Kutna Hora, 284 01
CzechiaSite Not Available
Neuroterapie KH, s.r.o.
Kutna Hora, 284 01
CzechiaActive - Recruiting
Medical Services Prague S R O
Praha 6, 16000
CzechiaSite Not Available
Medical Services Prague s.r.o.
Praha 6, 16000
CzechiaSite Not Available
Institut Neuropsychiatricke pece
Praha 8, 186 00
CzechiaSite Not Available
CHU de Brest - Hopital de la Cavale Blanche
Bohars, 29820
FranceSite Not Available
CHU de Brest - Hôpital de la Cavale Blanche
Bohars, 29820
FranceActive - Recruiting
CHU Clermont-Ferrand - Hopital Gabriel Montpied
Clermont Ferrand, 63000
FranceSite Not Available
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Douai, 59500
FranceSite Not Available
CHU Lapeyronie
Montpellier Cedex 5, 34295
FranceSite Not Available
CHU de Nantes hotel Dieu
Nantes, 44093
FranceSite Not Available
CHU de Nantes hotel-Dieu
Nantes, 44093
FranceActive - Recruiting
CHU de Nantes hôtel-Dieu
Nantes, 44093
FranceSite Not Available
Hopital Sainte Anne
Paris, 75674
FranceSite Not Available
CHRU de Tours Clinique Psychiatrique Universitaire
Tours cedex 9, 37044
FranceSite Not Available
Mental Clinic Sakurazaka
Fukuoka-shi, 810-0023
JapanSite Not Available
Rainbow & Sea Hospital
Karatsu-shi, 847-0031
JapanSite Not Available
Kishiro Mental Clinic
Kawasaki-shi, 214-0014
JapanSite Not Available
Osaka City General Hospital
Osaka, 534-0021
JapanSite Not Available
Sangenjaya neurology-psychosomatic clinic
Setagaya-ku, 154-0004
JapanSite Not Available
Maynds Tower Mental Clinic
Shibuya-ku, 151-0053
JapanSite Not Available
Yutokuhosshinkai Himeno Tomomi Clinic
Shinagawa-ku, 141-0032
JapanSite Not Available
Ohwa Mental Clinic
Toshima-ku, 170-0002
JapanSite Not Available
Barclay Imuro Mental Clinic
Urasoe-shi, 901-2104
JapanSite Not Available
Sanseikai Shioiri Mental Clinic
Yokosuka-shi, 238-0042
JapanSite Not Available
Bucheon St. Mary's Hospital
Bucheon-si, 14647
Korea, Republic ofSite Not Available
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofSite Not Available
CHA University ilsan Medical Center
Goyang, 10414
Korea, Republic ofSite Not Available
Korea University Ansan Hospital
Gyeonggi-do, 15355
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofSite Not Available
KyungHee University Hospital
Seoul, 02447
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 3080
Korea, Republic ofSite Not Available
The Catholic University of Korea Yeouido St. Mary's Hospital
Seoul, 07345
Korea, Republic ofSite Not Available
The Catholic university of Korea, St. Vincent's Hospital
Suwon-si, 16247
Korea, Republic ofSite Not Available
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. 'SINACOR'
Culiacan, 80230
MexicoSite Not Available
Alfredo Rizo Mendez
Guadalajara, 44689
MexicoSite Not Available
Hospital Aranda de la Parra S.A. de C.V.
Leon, 37000
MexicoSite Not Available
Instituto de Informacion e Investigacion en Salud Mental A.C.
Monterrey, 64710
MexicoSite Not Available
Bind Investigaciones S.C.
San Luis Potosi, 78213
MexicoSite Not Available
Clinsante Osrodek Badan Klinicznych
Bydgoszcz, 85 794
PolandSite Not Available
Centrum Medyczne Care Clinic Katowice
Katowice, 40568
PolandSite Not Available
Przychodnia Syntonia
Kielce, 25-103
PolandSite Not Available
Filip Rybakowski Specjalistyczna Praktyka Lekarska
Poznan, 60-744
PolandSite Not Available
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, 62-002
PolandSite Not Available
Institute of Mental Health Serbia
Belgrade, 11000
SerbiaSite Not Available
Special Neuropsychiatric Hospital Kovin
Kovin, 26220
SerbiaSite Not Available
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Clinical Center Nis
Nis, 18000
SerbiaSite Not Available
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Knezevac, 23330
SerbiaSite Not Available
Psychomed-Svatosavsky, s.r.o.
Banska Bystrica, 97401
SlovakiaSite Not Available
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
Bojnice, 97201
SlovakiaSite Not Available
Psychiatricka Ambulancia Mentum S.R.O.
Bratislava, 82007
SlovakiaSite Not Available
Epamed sro
Koshice, 040 11
SlovakiaSite Not Available
Univerzitna nemocnica L. Pasteura Kosice
Kosice, 04190
SlovakiaSite Not Available
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovsky Mikulas, 03123
SlovakiaSite Not Available
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavska Sobota, 97901
SlovakiaSite Not Available
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, 97901
SlovakiaSite Not Available
Crystal Comfort s.r.o.
Vranov nad Toplou, 9301
SlovakiaSite Not Available
BONA MEDIC, s.r.o.
Zlate Moravce, 95301
SlovakiaSite Not Available
Cape Town Clinical Research Centre
Cape Town, 7530
South AfricaSite Not Available
Gert Bosch - Pretoria South Africa
Pretoria, 181
South AfricaActive - Recruiting
Gert Bosch Pretoria South Africa
Pretoria, 181
South AfricaSite Not Available
Somerset West Clinical Research Unit
Strand, 7140
South AfricaSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
Cheng Hsin General Hospital
Taipei, 112
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Taipei Medical University
Taipei City, 110
TaiwanSite Not Available
University of Sussex
Brighton, BN1 9RY
United KingdomSite Not Available
Royal Edinburgh Hospital
Edinburgh, EH10 5HF
United KingdomSite Not Available
Institute of Psychiatry
London, SE5 8AF
United KingdomSite Not Available
Renfrewshire CMHT
Paisley, PA1 1JS
United KingdomSite Not Available
Moorgreen Hospital
Southampton, SO30 3JB
United KingdomSite Not Available
Kingshill Research Centre
Swindon, SN3 6BW
United KingdomSite Not Available
Crisis Resolution and Home Treatment Team
Wigan And Leigh, WN7 1YN
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Harmonex Neuroscience Research
Dothan, Alabama 36303
United StatesSite Not Available
NoesisPharma Research
Phoenix, Arizona 85016
United StatesSite Not Available
Pharmacology Research Institute
Encino, California 91316
United StatesSite Not Available
Sunwise Clinical Research
Lafayette, California 94549
United StatesSite Not Available
Pacific Neuropsychiatric Specialists
Orange, California 92868
United StatesSite Not Available
Stanford University School of Medicine
Palo Alto, California 94304-1212
United StatesSite Not Available
Prospective Research Innovations Inc
Rancho Cucamonga, California 91730
United StatesSite Not Available
Prospective Research Innovations, Inc.
Rancho Cucamonga, California 91730
United StatesActive - Recruiting
University of California San Diego Medical Center
San Diego, California 92103
United StatesSite Not Available
CMB Clinical Trials
Santee, California 92071
United StatesSite Not Available
California Neuroscience Research
Sherman Oaks, California 91403
United StatesSite Not Available
Pacific Clinical Research Medical Group
Upland, California 91786
United StatesSite Not Available
Next Level Clinical Trials, LLC
West Covina, California 91790
United StatesSite Not Available
MCB Clinical Research Centers LLC
Colorado Springs, Colorado 80910
United StatesSite Not Available
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado 80910
United StatesActive - Recruiting
CNS Clinical Research Group
Coral Springs, Florida 33067
United StatesSite Not Available
Sarkis Clinical Trials
Gainesville, Florida 32607
United StatesSite Not Available
New Life Medical Research Center, Inc.
Hialeah, Florida 33012
United StatesSite Not Available
K2 Medical Research
Maitland, Florida 32751
United StatesSite Not Available
Ezy Medical Research
Miami, Florida 33175
United StatesSite Not Available
Felicidad Medical Research
Miami, Florida 33184
United StatesSite Not Available
Florida Research Center Inc.
Miami, Florida 33174
United StatesSite Not Available
Global Medical Institutes
Miami, Florida 33125
United StatesSite Not Available
LCC Medical Research Institute Inc
Miami, Florida 33126
United StatesSite Not Available
LCC Medical Research Institute, Inc
Miami, Florida 33126
United StatesActive - Recruiting
Vital Care Research
Miami, Florida 33122
United StatesSite Not Available
Bravo Health Care Center
North Bay Village, Florida 33141
United StatesSite Not Available
APG Research LLC
Orlando, Florida 32803
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesActive - Recruiting
Combined Research Orlando
Orlando, Florida 32803
United StatesSite Not Available
Quantum Laboratories
Pompano Beach, Florida 33064
United StatesSite Not Available
CDC Research Institute LLC
Port Saint Lucie, Florida 34952
United StatesSite Not Available
Psychiatric Medicine Associates
Skokie, Illinois 60076
United StatesSite Not Available
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
CBH Health
Gaithersburg, Maryland 20877
United StatesSite Not Available
Michigan Clinical Research Institute
Ann Arbor, Michigan 48105
United StatesSite Not Available
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
Revive Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Midwest Research Group
Saint Charles, Missouri 63304
United StatesSite Not Available
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska 68526
United StatesSite Not Available
Bio Behavioral Health
Toms River, New Jersey 08755
United StatesSite Not Available
Erie County Medical Center
Buffalo, New York 14215
United StatesSite Not Available
Neurobehavioral Research, Inc
Cedarhurst, New York 11516
United StatesSite Not Available
Manhattan Behavioral Medicine
New York, New York 10036
United StatesSite Not Available
New Hope Clinical Research
Charlotte, North Carolina 28211
United StatesSite Not Available
Monroe Biomedical Research
Monroe, North Carolina 28112
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Wexner Medical Center at the Ohio State University
Columbus, Ohio 43221
United StatesSite Not Available
Conrad Clinical Research
Edmond, Oklahoma 73013
United StatesSite Not Available
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma 73118
United StatesSite Not Available
Sooner Clinical Research
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
United StatesActive - Recruiting
Lehigh Center for Clinical Research LLC
Allentown, Pennsylvania 18103
United StatesSite Not Available
Global Medical Institutes
Moosic, Pennsylvania 18507
United StatesSite Not Available
Clinical Trials of South Carolina
Charleston, South Carolina 29406
United StatesSite Not Available
Donald J Garcia Jr MD PA
Austin, Texas 78737
United StatesSite Not Available
Donald J. Garcia, Jr., MD, PA
Austin, Texas 78737
United StatesActive - Recruiting
Relaro Medical Trials
Dallas, Texas 75243
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75247-9119
United StatesSite Not Available
New Horizon Medical Group
Houston, Texas 77042
United StatesSite Not Available
R and H Clinical Research
Stafford, Texas 77477
United StatesSite Not Available
Cedar Psychiatry
Murray, Utah 84107
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
Core Clinical Research
Everett, Washington 98201
United StatesSite Not Available
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