Clinical trial NCT05518149: A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Official title: An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Aticaprant
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).


Eligibility criteria: Inclusion Criteria:

Transferred-entry participants:

-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study

Direct-entry participants:

* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* 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 the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)

Direct-entry and Transferred-entry Participants:

-Participants should not take any prohibited medication or food supplements

Exclusion Criteria:

Transferred-entry Participants:

* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments

Direct-entry Participants:

* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 54
measure: Number of Participants with Adverse Events of Special Interest (AESI)
timeFrame: Up to Week 54
measure: Number of Participants with Change from Baseline in Vital Signs Abnormalities
timeFrame: Up to Week 54
measure: Number of Participants with Abnormal Body Weight
timeFrame: Up to Week 54
measure: Number of Participants with Abnormal Body Mass Index (BMI)
timeFrame: Up to Week 54
measure: Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 54
measure: Number of Participants with Abnormalities in Clinical Laboratory parameters
timeFrame: Up to Week 54
measure: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Week 54
measure: Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)
timeFrame: Up to Week 54
measure: Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score
timeFrame: Up to Week 54
Secondary outcomes:
measure: Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time
timeFrame: Baseline up to Week 54
measure: Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time
timeFrame: Baseline up to Week 54
measure: Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time
timeFrame: Baseline up to Week 54
measure: Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time
timeFrame: Baseline up to Week 54
measure: Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time
timeFrame: Week 54
measure: Percentage of Participants with Remission of Depressive Symptoms Over Time
timeFrame: Week 54
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - The Kirklin Clinic
state: Alabama
city: Tucson
country: United States
facility: SW Biomedical Research LLC
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center Inc
state: California
city: Culver City
country: United States
facility: Proscience Research Group
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists LLC
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Long Beach
country: United States
facility: Asclepes Research
state: California
city: Oceanside
country: United States
facility: Excell Research Inc
state: California
city: Orange
country: United States
facility: Pacific Neuropsychiatric Specialists
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Santee
country: United States
facility: CMB Clinical Trials
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Ltd
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: West Covina
country: United States
facility: Next Level Clinical Trials, LLC
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers LLC
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Incorporated
state: Florida
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Medical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute Inc
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Maitland
country: United States
facility: Vertex Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: Meridian International Research
state: Florida
city: Miami Lakes
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Vital Care Research
state: Florida
city: Miami
country: United States
facility: Global Medical Institutes
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute Inc
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: A Plus Research
state: Florida
city: Miami
country: United States
facility: Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Miami
country: United States
facility: Felicidad Medical Research
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center
state: Florida
city: Ocoee
country: United States
facility: K2 Medical Research
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: APG Research LLC
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute LLC
state: Florida
city: Tampa
country: United States
facility: USF, Department of Psychiatry and Behavioral Neurosciences
state: Florida
city: Berwyn
country: United States
facility: Research Network America
state: Illinois
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates LLC
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute
state: Michigan
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center (PCRC)
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: New York
country: United States
facility: Fieve Clinical Research Inc
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites LLC
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
state: Ohio
city: Columbus
country: United States
facility: Wexner Medical Center at the Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Center for Health and Wellness
state: Ohio
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research LLC
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman School of Medicine
state: Pennsylvania
city: Austin
country: United States
facility: Austin Clinical Trial Partners
state: Texas
city: Bellaire
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Katy
country: United States
facility: R and H Clinical Research
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Murray
country: United States
facility: Cedar Psychiatry
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: INSA Instituto de Neurociencias San Agustín
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: CENydET - Centro Neurobiologico y de Stress Traumatico
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: STAT Research S A
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CIPREC
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad de Mendoza
country: Argentina
facility: Resolution
city: Cordoba
country: Argentina
facility: CEN Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Fundacion Lennox
city: Cordoba
country: Argentina
facility: Centro Medico Luquez
city: Córdoba
country: Argentina
facility: Instituto Medico DAMIC
city: La Plata
country: Argentina
facility: CENPIA
city: La Plata
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Ávila
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Rosario
country: Argentina
facility: Instituto Medico de La Fundacion Estudios Clinicos
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de UMCB
city: Santiago del Estero
country: Argentina
facility: Clinica El Jardin
city: Frankston
country: Australia
facility: Peninsula Therapeutic & Research Group
city: Melbourne
country: Australia
facility: Albert Road Clinic
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Alken
country: Belgium
facility: Anima
city: Bruxelles
country: Belgium
facility: C.H.U. Brugmann
city: Duffel
country: Belgium
facility: Pz Duffel
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Curitiba
country: Brazil
facility: Trial Tech Tecnologia em Pesquisas com Medicamentos
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceara Hospital Universitario Walter Cantidio
city: Goiania
country: Brazil
facility: Instituto Goiano de Neuropsiquiatria
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica Ltda
city: Sao Bernardo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: BR Trials
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Cherven Bryag
country: Bulgaria
facility: Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
city: Plovdiv
country: Bulgaria
facility: Ambulatory Group practice for specialized help in psychiary Philipopolis ODD
city: Plovdiv
country: Bulgaria
facility: Medical Center Mentalcare OOD
city: Ruse
country: Bulgaria
facility: Mental Health Center - Rousse
city: Sofia
country: Bulgaria
facility: Medical Center St. Naum
city: Sofia
country: Bulgaria
facility: MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica, OOD
city: Varna
country: Bulgaria
facility: Diagnostic Consulting Center Mladost - M Varna
city: Veliko Tarnovo
country: Bulgaria
facility: Mental Health Center - Veliko Tarnovo EOOD
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke Inc
state: Quebec
city: Baoding
country: China
facility: Hebei Mental Health Center
city: Beijing
country: China
facility: Beijing Anding Hospital of Capital Medical University
city: Beijing
country: China
facility: Peking University Sixth Hospital
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Shanghai
country: China
facility: Shanghai Mental Health Center
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Wuhan
country: China
facility: Wuhan Mental Health Center
city: Wuhu
country: China
facility: Wuhu Hospital of Beijing Anding hospital
city: XI An
country: China
facility: XiAn Mental Healthcare Center
city: Brno
country: Czechia
facility: Psychiatricka ambulance, MUDr. Marta Holanova
city: Klecany
country: Czechia
facility: Narodni ustav dusevniho zdravi
city: Kutna Hora
country: Czechia
facility: Neuroterapie KH S R O
city: Plzen
country: Czechia
facility: A Shine S R O
city: Prague 5
country: Czechia
facility: Praglandia s r o
city: Praha 10
country: Czechia
facility: Clintrial s r o
city: Praha 10
country: Czechia
facility: AD71 s.r.o.
city: Praha 6
country: Czechia
facility: NeuropsychiatrieHK, s.r.o.
city: Praha 6
country: Czechia
facility: Medical Services Prague S R O
city: Praha 8
country: Czechia
facility: Institut Neuropsychiatricke pece
city: Usti nad Labem
country: Czechia
facility: Psychiatricka ordinace
city: Bohars
country: France
facility: CHU de Brest - Hopital de la Cavale Blanche
city: Clermont Ferrand
country: France
facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied
city: Douai
country: France
facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Paris
country: France
facility: Hopital Sainte Anne
city: Tours cedex 9
country: France
facility: CHRU de Tours Clinique Psychiatrique Universitaire
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Kalocsa
country: Hungary
facility: Dr Mathe es Tarsa Bt
city: Pecs
country: Hungary
facility: PsychoTech Kft
city: Szekszárd
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria Mater Domini
city: Lecce
country: Italy
facility: AUSL LE di Lecce
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
city: Bucheon
country: Korea, Republic of
facility: The Catholic University Of Korea St Mary'S Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Bialystok
country: Poland
facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
city: Bydgoszcz
country: Poland
facility: Clinsante Osrodek Badan Klinicznych
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI House sp z o o
city: Katowice
country: Poland
facility: Centrum Medyczne Care Clinic Katowice
city: Lodz
country: Poland
facility: Specjalistyczna Indywidualna Praktyka Lekarska
city: Poznan
country: Poland
facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska
city: Suchy Las
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
city: Torun
country: Poland
facility: Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Hospital CUF Inf. Santo
city: Lisboa
country: Portugal
facility: Fund. Champalimaud
city: Banska Bystrica
country: Slovakia
facility: Psychomed-Svatosavsky, s.r.o.
city: Bojnice
country: Slovakia
facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
city: Bratislava
country: Slovakia
facility: Psychiatricka Ambulancia Mentum S.R.O.
city: Koshice
country: Slovakia
facility: Epamed sro
city: Kosice
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura Kosice
city: Liptovsky Mikulas
country: Slovakia
facility: Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
city: Rimavska Sobota
country: Slovakia
facility: Psychiatricka Ambulancia Psycholine S.R.O.
city: Vranov nad Toplou
country: Slovakia
facility: Crystal Comfort s.r.o.
city: Cape Town
country: South Africa
facility: Cape Town Clinical Research Centre
city: Pretoria
country: South Africa
facility: Gert Bosch Pretoria South Africa
city: Strand
country: South Africa
facility: Somerset West Clinical Research Unit
city: Barcelona
country: Spain
facility: Institucion Hosp Hestia Palau
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Ponferrada
country: Spain
facility: Hosp. El Bierzo
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Vitoria
country: Spain
facility: Hosp. Psiquiatrico Alava
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum Stockholm
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: London
country: United Kingdom
facility: Institute of Psychiatry
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References: