676
Participants
Start Date
August 21, 2020
Primary Completion Date
January 20, 2022
Study Completion Date
July 15, 2022
Esketamine 28 mg
Esketamine will be self-administered at a dose of 28 mg as nasal spray.
Esketamine 56 mg
Esketamine will be self-administered at a dose of 56 mg as nasal spray.
Esketamine 84 mg
Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.
Quetiapine XR 50 mg
Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
Quetiapine XR 100 mg
Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
Quetiapine XR 150 mg
Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
SSRI/SNRI
Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).
Taipei Medical University, Taipei
Psykiatrinen Palvelukeskus Solvum Oy, Helsinki
Chang Gung Memorial Hospital, Taoyuan District
Changhua Christian Hospital, Changhua
Hualien Tzu Chi Hospital, Hualien City
Schmitz and Schmitz, Vienna
Semmelweis Egyetem, Budapest
Medical University Vienna MUV, Vienna
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum, Sofia
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu, Budapest
Processus Kft, Budapest
MHC - Sofia, EOOD, Sofia
Centre for Mental Health Prof.N.Shipkovenski EOOD, Sofia
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD, Sofia
Sykehuset Ostfold, Moss
Instituto de Neurociencias San Agustin, La Plata
C I A P Centro de investigacion y Asistencia en Psiquiatria, Rosario
Pz Duffel, Duffel
Carl-Thiem-Klinikum Cottbus gGmbH, Cottbus
Bugat Pal Korhaz, Gyöngyös
Sint-Franciskusziekenhuis, Heusden-Zolder
Anima, Alken
CHU de Liege, Liège
Mental Health Center - Plovdiv, Plovdiv
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház, Debrecen
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza
Clinique Psychiatrique des Frères Alexiens, Henri-Chapelle
Fundacion Lennox, Córdoba
Haukeland University Hospital, Hordaland
UMHAT 'Dr. Georgi Stranski', EAD, Pleven
Hacettepe University Medical Faculty, Ankara
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza, Kalocsa
State Psychiatric Hospital Kardzhali, Kardzhali
Psykiatrien i Region Syddanmark, Esbjerg N
St Olav University Hospital, Trondheim
Mental Health Center - Rousse, Rousse
Cape Town Clinical Research Centre, Cape Town
SRH Waldklinikum Gera GmbH, Gera
Flexivest 14 Research, Cape Town
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs
Universitatsklinikum Jena, Jena
Medical University Graz, Graz
Aalborg University Hospital, Aalborg
ARIADNE, Lede
Clintrial s r o, Prague
National Taiwan University Hospital, Taipei
Mackay Memorial Hospital, Taipei
Emovis GmbH, Berlin
Taipei Veterans General Hospital, Taipei
Aiginition Hospital of Athens, Athens
Charite Campus Benjamin Franklin, Berlin
Medizinisches Versorgungszentrum LiO GmbH, Berlin
Alexander Schulze - Germany, Berlin
Praxis Dr. med. Kirsten Hahn, Berlin
Vivantes Klinikum Spandau, Berlin
Medical Services Prague S R O, Prague
Bursa Yuksek Ihtisas Training and Research Hospital, Bursa
Uludag University Medical Faculty, Bursa
Oberhavel Kliniken GmbH, Hennigsdorf
Ruppiner Kliniken, Neuruppin
Evangelisches Krankenhaus Bethanien gGmbH, Greifswald
Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany, Stralsund
Institut Neuropsychiatricke pece, Prague
Somni Bene GmbH, Schwerin
Klinische Forschung Schwerin GmbH, Schwerin
Universitaetsklinik Hamburg-Eppendorf, Hamburg
Klinische Forschung Hamburg, Hamburg
ProbarE i Lund AB, Lund
University General Hospital of Rio Patras, Pátrai
Klinische Forschung Hannover-Mitte GmbH, Hanover
Medizinische Hochschule Hannover, Hanover
Hospital Raja Permaisuri Bainun, Ipoh
A Shine S R O, Pilsen
Bakirkoy Mental Health Training and Research Hospital, Istanbul
Ege Universitesi Tip Fakultesi, Izmir
Erenkoy Mental Health Hospital, Istanbul
Uskudar University Neuropsychiatry Hospital, Istanbul
Georg August Universitat Universitatsmedizin Gottingen, Göttingen
Universitaetsklinikum Magdeburg A.oe.R, Magdeburg
Psykiatriska kliniken, Gothenburg
Selcuk University Medical Faculty, Konya
Hospital Pengajar Universiti Putra Malaysia, Serdang
Klinikum Dortmund gGmbH, Dortmund
Shalvata Mental Health Center, Hod HaSharon
University General Hospital of Ioannina, Ioannina
Johanniter Krankenhaus Oberhausen, Oberhausen
Universitatsklinikum Munster, Münster
Republican Scientific and Practical Center of Mental Health, Almaty
NeuropsychiatrieHK, s.r.o., Hradec Kralove-Vekose
Hospital Kuala Lumpur, Kuala Lumpur
American Center for Psychiatry and Neurology, Abu Dhabi
Universitaetsklinikum der RWTH Aachen, Aachen
Sheba Medical Center, Ramat Gan
Universitatsklinikum Bonn, Bonn
424 Military Hospital of Thessaloniki, Thessaloniki
Liv Hospital, Samsun
Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz
Rheinhessen Fachklinik Alzey, Alzey
Psychiatric Hospital of Thessaloniki, Thessaloniki
G Papanikolaou Hospital of Thessaloniki, Thessaloniki
Namik Kemal University, Tekirdağ
University Malaya Medical Centre, Kuala Lumpur
Psychiatricka ambulance Saint Anne s.r.o., Brno
Universitatsklinikum Frankfurt, Frankfurt am Main
Chonnam National University Hospital, Gwangju
Psychiatricka ambulance, MUDr. Marta Holanova, Brno
Universitätsklinikum des Saarlandes, Homburg
Universität Heidelberg, Heidelberg
East-Kazakhstan Regional Centre of Mental Health, Ust-Kamenogorsk
Savon Psykiatripalvelu, Kuopio
Hospital Tuanku Jaafar, Seremban
National Cheng Kung University Hospital, Tainan City
Psychiatric Clinic 'Agios Charalampos', Heraklion
Venizeleio General Hospital, Crete
Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik, Freiburg im Breisgau
Kai-Syuan Psychiatric Hospital, Kaohsiung City
Chang Gung Memorial Hospital, Kaohsiung City
Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik, Pfaffenhofen
Praxis Prof. Steinwachs, Nuremberg
Psykiatriska kliniken, Luleå
Rambam Medical Center, Haifa
Geha Mental Health Center, Petah Tikva
Tel Aviv Sourasky Medical Center, Telaviv
Beer Yaakov Mental Health Center, Lod
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales, Buenos Aires
FunDaMos, Buenos Aires
CEN Consultorios Especializados en Neurociencias, Córdoba
Instituto Medico DAMIC, Córdoba
Sanatorio Prof Leon S Morra S A, Córdoba
CPN - Centro de Pesquisa em Neurociências Ltda, Belo Horizonte
Trial Tech Tecnologia em Pesquisas com Medicamentos, Curitiba
Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro
C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana), São Paulo
BR Trials, São Paulo
AD71 s.r.o., Prague
Mederon LTD at ARTES, Helsinki
Klinikum Chemnitz gGmbH, Chemnitz
Universitatsklinikum Carl Gustav Carcus Dresden, Dresden
Panakeia - Arzneimittelforschung GmbH, Leipzig
Pharmakologisches Studienzentrum Chemnitz GmbH, Mittweida
'Dafni' Psychiatric Hospital of Attica, Athens
Petz Aladar Megyei Oktato Korhaz, Győr
Medical Center for Psychological Healt SME, Nur-Sultan
Brain Research Center, Amsterdam
AMC, Amsterdam
LUMC, Leiden
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk, Bialystok
Osrodek Badan Klinicznych CLINSANTE S C, Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Gdansk
Centrum Badan Klinicznych PI House sp z o o, Gdansk
Centrum Medyczne Care Clinic Katowice, Katowice
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS, Leszno
Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego, Lodz
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych, Lodz
Centrum Medyczne Luxmed Sp z o o, Lublin
Osrodek Badan Klinicznych CLINSANTE S C, Torun
Hospital de Braga, Braga
Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa, Guilhufe - Penafiel
Hosp. Cuf Tejo, Lisbon
Fund. Champalimaud, Lisbon
Centro Hospitalar de Lisboa Norte Hospital Santa Maria, Lisbon
Uls Loures Odivelas - Hosp. Loures, Loures
Gert Bosch Pretoria South Africa, Garsfontein
Wonkwang University Hospital, Iksan
KyungHee University Hospital, Seoul
Korea University Anam Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Samsung Medical Center, Seoul
Affecta Pskyiatrimottagning, Halmstad
ONE LIFETIME Lakarmottagning, Skövde
ProbarE i Stockholm AB, Stockholm
Lead Sponsor
Janssen-Cilag International NV
INDUSTRY