Clinical trial NCT04338321: A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
Official title: A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Detailed description: A depressive state with classical symptoms such as low (depressive/sad) mood, markedly diminished interest in activities, significant weight loss/gain, insomnia or hypersomnia, psychomotor agitation/retardation, excessive fatigue, inappropriate guilt, diminished concentration, and recurrent thoughts of death, persisting for more than 2 weeks is classified as major depressive disorder (MDD). The mechanism of action of ketamine is distinct from conventional antidepressants (ADs), which target the monoamines (serotonin, norepinephrine, and/or dopamine). Esketamine, the S-enantiomer of ketamine, is approved and widely used for the induction and maintenance of anesthesia via intramuscular or intravenous (IV) administration. There is a significant unmet need to develop novel AD treatments based on the relevant psychophysiological pathways underlying MDD. The goal of any novel treatment would be the rapid and long-lasting relief of depressive symptoms, especially in participants with treatment-resistant depression (TRD), who lack a sufficient response to the currently available treatment strategies. The study consists of a Screening Phase (up to 14 days), an Acute Phase (8 Weeks), a Maintenance Phase (24 Weeks) and a Safety Follow-up Phase (2 Weeks). Safety assessment includes adverse event, serious adverse events, physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, suicidal risk monitoring. The total duration of the study is approximately 36 Weeks for all participants.

Eligibility criteria: Inclusion Criteria:

* At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI)
* At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (\>=) 34
* Must be on a current antidepressive treatment that includes an selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake inhibitor (SNRI) at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC \[or local equivalent, if applicable\]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician. At baseline (Day 1) prior to randomization, the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current AD treatment are still met (that is nonresponse and minimal clinical improvement)
* The current antidepressive treatment, was immediately preceded by nonresponse to at least 1 but not more than 5 different, consecutive treatments (all within the current moderate to severe antidepressive episode) with anti-depressants (ADs) taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented
* Must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor \[SSRI/SNRI\])
* Must be on a single oral SSRI/SNRI on Day 1 prior to randomization

Exclusion Criteria:

* Received treatment with esketamine or ketamine in the current moderate to severe depressive episode
* Received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 milligram per day (mg/day)
* Had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT
* Has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview
* Received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
* has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the Mini International Neuropsychiatric Interview \[MINI\]), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, or antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
* age at onset of first episode of MDD was more than or equal to (\>=) 55 years
* has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator's clinical judgment; or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded

Primary outcomes:
measure: Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32
timeFrame: Week 32
measure: Change From Baseline in Clinician-rated Overall MADRS Score
timeFrame: Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
measure: Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)
timeFrame: Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
measure: Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF
timeFrame: Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
measure: Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
measure: Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF
timeFrame: Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
measure: Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF
timeFrame: Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
measure: Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF
timeFrame: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF
timeFrame: Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF
timeFrame: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF
timeFrame: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF
timeFrame: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF
timeFrame: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 35
measure: Number of Participants With TEAEs of Special Interest
timeFrame: Up to Week 35
measure: Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: FunDaMos
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
city: Cordoba
country: Argentina
facility: CEN Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Fundacion Lennox
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC
city: Cordoba
country: Argentina
facility: Sanatorio Prof Leon S Morra S A
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustin
city: Rosario
country: Argentina
facility: C I A P Centro de investigacion y Asistencia en Psiquiatria
city: Graz
country: Austria
facility: Medical University Graz
city: Vienna
country: Austria
facility: Schmitz and Schmitz
city: Vienna
country: Austria
facility: Medical University Vienna MUV
city: Alken
country: Belgium
facility: Anima
city: Duffel
country: Belgium
facility: Pz Duffel
city: Henri Chapelle
country: Belgium
facility: Clinique Psychiatrique des Frères Alexiens
city: Heusden-Zolder
country: Belgium
facility: Sint-Franciskusziekenhuis
city: Lede
country: Belgium
facility: ARIADNE
city: Liege
country: Belgium
facility: CHU de Liege
city: Belo Horizonte
country: Brazil
facility: CPN - Centro de Pesquisa em Neurociências Ltda
city: Curitiba
country: Brazil
facility: Trial Tech Tecnologia em Pesquisas com Medicamentos
city: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica Ltda
city: Sao Paulo
country: Brazil
facility: C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)
city: Sao Paulo
country: Brazil
facility: BR Trials
city: Kardzhali
country: Bulgaria
facility: State Psychiatric Hospital Kardzhali
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: Mental Health Center - Plovdiv
city: Rousse
country: Bulgaria
facility: Mental Health Center - Rousse
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
city: Sofia
country: Bulgaria
facility: MHC - Sofia, EOOD
city: Sofia
country: Bulgaria
facility: Centre for Mental Health Prof.N.Shipkovenski EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
city: Brno
country: Czechia
facility: Psychiatricka ambulance Saint Anne s.r.o.
city: Brno
country: Czechia
facility: Psychiatricka ambulance, MUDr. Marta Holanova
city: Hradec Kralove-Vekose
country: Czechia
facility: NeuropsychiatrieHK, s.r.o.
city: Plzen
country: Czechia
facility: A Shine S R O
city: Prague
country: Czechia
facility: Institut Neuropsychiatricke pece
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: Medical Services Prague S R O
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Esbjerg N
country: Denmark
facility: Psykiatrien i Region Syddanmark
city: Helsinki
country: Finland
facility: Mederon LTD at ARTES
city: Helsinki
country: Finland
facility: Psykiatrinen Palvelukeskus Solvum Oy
city: Kuopio
country: Finland
facility: Savon Psykiatripalvelu
city: Aachen
country: Germany
facility: Universitaetsklinikum der RWTH Aachen
city: Alzey
country: Germany
facility: Rheinhessen Fachklinik Alzey
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum LiO GmbH
city: Berlin
country: Germany
facility: Alexander Schulze - Germany
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus gGmbH
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carcus Dresden
city: Frankfurt Am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik
city: Gera
country: Germany
facility: SRH Waldklinikum Gera GmbH
city: Gottingen
country: Germany
facility: Georg August Universitat Universitatsmedizin Gottingen
city: Greifswald
country: Germany
facility: Evangelisches Krankenhaus Bethanien gGmbH
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universität Heidelberg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Leipzig
country: Germany
facility: Panakeia - Arzneimittelforschung GmbH
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken
city: Nurnberg
country: Germany
facility: Praxis Prof. Steinwachs
city: Oberhausen
country: Germany
facility: Johanniter Krankenhaus Oberhausen
city: Pfaffenhofen
country: Germany
facility: Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik
city: Schwerin
country: Germany
facility: Somni Bene GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Stralsund
country: Germany
facility: Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany
city: Athens
country: Greece
facility: Aiginition Hospital of Athens
city: Athens
country: Greece
facility: 'Dafni' Psychiatric Hospital of Attica
city: Crete
country: Greece
facility: Venizeleio General Hospital
city: Heraklion
country: Greece
facility: Psychiatric Clinic 'Agios Charalampos'
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Patras
country: Greece
facility: University General Hospital of Rio Patras
city: Thessaloniki
country: Greece
facility: 424 Military Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Psychiatric Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: G Papanikolaou Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
city: Budapest
country: Hungary
facility: Processus Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Kalocsa
country: Hungary
facility: Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
city: Lod
country: Israel
facility: Beer Yaakov Mental Health Center
city: Petach Tikva
country: Israel
facility: Geha Mental Health Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Telaviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Almaty
country: Kazakhstan
facility: Republican Scientific and Practical Center of Mental Health
city: Nur-Sultan
country: Kazakhstan
facility: Medical Center for Psychological Healt SME
city: Ust'-Kamenogorsk
country: Kazakhstan
facility: East-Kazakhstan Regional Centre of Mental Health
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Serdang
country: Malaysia
facility: Hospital Pengajar Universiti Putra Malaysia
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Amsterdam
country: Netherlands
facility: Brain Research Center
city: Amsterdam
country: Netherlands
facility: AMC
city: Leiden
country: Netherlands
facility: LUMC
city: Hordaland
country: Norway
facility: Haukeland University Hospital
city: Moss
country: Norway
facility: Sykehuset Ostfold
city: Trondheim
country: Norway
facility: St Olav University Hospital
city: Bialystok
country: Poland
facility: Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
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: Leszno
country: Poland
facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
city: Lodz
country: Poland
facility: Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
city: Lodz
country: Poland
facility: SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp z o o
city: Torun
country: Poland
facility: Osrodek Badan Klinicznych CLINSANTE S C
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guilhufe - Penafiel
country: Portugal
facility: Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
city: Lisboa
country: Portugal
facility: Fund. Champalimaud
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte Hospital Santa Maria
city: Lisbon
country: Portugal
facility: Hosp. Cuf Tejo
city: Loures
country: Portugal
facility: Uls Loures Odivelas - Hosp. Loures
city: Cape Town
country: South Africa
facility: Cape Town Clinical Research Centre
city: Cape Town
country: South Africa
facility: Flexivest 14 Research
city: Garsfontein
country: South Africa
facility: Gert Bosch Pretoria South Africa
city: Goteborg
country: Sweden
facility: Psykiatriska kliniken
city: Halmstad
country: Sweden
facility: Affecta Pskyiatrimottagning
city: Lulea
country: Sweden
facility: Psykiatriska kliniken
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Skovde
country: Sweden
facility: ONE LIFETIME Lakarmottagning
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: ChangHua
country: Taiwan
facility: Changhua Christian Hospital
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Kaohsiung
country: Taiwan
facility: Kai-Syuan Psychiatric Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Mental Health Training and Research Hospital
city: Istanbul
country: Turkey
facility: Erenkoy Mental Health Hospital
city: Istanbul
country: Turkey
facility: Uskudar University Neuropsychiatry Hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty
city: Samsun
country: Turkey
facility: Liv Hospital
city: Tekirdag
country: Turkey
facility: Namik Kemal University
city: Abu Dhabi
country: United Arab Emirates
facility: American Center for Psychiatry and Neurology
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trials
role: STUDY_DIRECTOR
References: