230
Participants
Start Date
June 15, 2017
Primary Completion Date
April 11, 2019
Study Completion Date
April 11, 2019
Esketamine
Participants will receive intranasal esketamine 84 milligram (mg) two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
Placebo
Participants will receive intranasal placebo two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
Standard of Care
The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.
Medical University Vienna MUV, Vienna
Klinikum Wels Grieskirchen, Wels
AZ Sint Jan Brugge Oostende AV, Bruges
Inst. Internac. Neurociencias Aplicadas, Barcelona
UZ Gent, Ghent
ARIADNE, Lede
Vilnius Mental Health Center, Vilnius
The Zucker Hillside Hospital, Glen Oaks
Stony Brook University Medical Center, Stony Brook
Vseobecna Fakultní Nemocnice, Prague
Bursa Sevket Yilmaz Research and Training Hospital, Bursa
Uludag University Medical Faculty, Bursa
Ústrední vojenské nemocnice Praha, Prague
John Hopkins Hospital, Baltimore
Narodni ustav dusevniho zdravi, Klecany
University of North Carolina, Chapel Hill
Hôpital de Bohars, Bohars
CHU Caremeau, Nîmes
Atlanta Behavioral Research, LLC, Atlanta
Clinica Univ. de Navarra, Pamplona
CHU Toulouse, Toulouse
University of Miami Health System, Miami
Innovative Clinical Research Inc, North Miami
University of South Florida, Tampa
CHRU Montpellier Hopital Lapeyronie, Montpellier
Sisli Etfal Research Training Hospital, Istanbul
East Tennessee State University, Johnson City
CHU Saint Etienne Hopital Nord, Saint-Priest-en-Jarez
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience, Cincinnati
Hosp. Univ. de Basurto, Bilbao
University of Wisconsin Medical Center, Madison
Samsun Psychiatric Hospital, Samsun
Neuroscience Research Institute, Winfield
Fakultni nemocnice Brno, Brno
Memorial Medical Center, Springfield
Lake Charles Clinical Trials, Lake Charles
Nemocnice s pol. Havirov, p.o., Havířov
Hopital Sainte Anne, Paris
Altea Research Institute, Las Vegas
Sharp Mesa Vista Hospital, San Diego
University of California San Diego/Psychiatry, San Diego
University of Conneticut School of Medicine, Farmington
Clínica Privada Banfield S.A, Banfield
Hospital Fleni, Ciudad de Buenos Aires
Sanatorio Prof. Leon S. Morra, Córdoba
Clinica Privada de Salud Mental Santa Teresa de Ávila, La Plata
Universidade Federal De Minas Gerais - Hospital das Clínicas, Belo Horizonte
Universidade Federal Do Ceara, Fortaleza
Instituto Bairral de Psiquiatria, Itapira
Hospital Universitario Professor Edgar Santos, Salvador
CEMEC - Centro Multidisciplinar de Estudos Clínicos, Santo André
Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo
St. Michael's Hospital, Toronto
Institut universitaire en sante mentale de Montreal, Montreal
Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas
Republic Kaunas Hospital, Kaunas County
Uniwersyteckie Centrum Kliniczne, Gdansk
Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny, Gorlice
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych, Lodz
Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza, Pruszków
Hosp Univ Vall D Hebron, Barcelona
Janssen Research & Development, LLC
INDUSTRY