54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

PHASE3CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

June 9, 2017

Primary Completion Date

December 18, 2018

Study Completion Date

December 18, 2018

Conditions
Depressive Disorder, Major
Interventions
DRUG

Esketamine

Intranasal esketamine solution 84 milligram (mg)

OTHER

Placebo

Intranasal Placebo solution

OTHER

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.

Trial Locations (56)

114

Tri-Service Genaral Hospital, Neihu District

1125

Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu, Budapest

Semmelweis Egyetem Kútvölgyi Klinikai Tömb, Budapest

1135

Nyiro Gyula Korhaz, Budapest

1606

Military Medical Academy Multiprofile Hospital for Active Treatment Sofia, Sofia

3080

Seoul National University Hospital, Seoul

4002

UMHAT 'Sveti Georgi'-Plovdiv, Plovdiv

5500

State Psychiatric Hospital - Lovech, Lovech

7003

Regional Psychiatric Dispansery, Bulgaria

7530

Juan Schrönen - Western Cape South Africa, Welgemoed

7550

Flexivest 14 Research, Cape Town

7623

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

8001

Mental Health Center Prof. Dr. Ivan Temkov, Burgas

8006

Inst. Internac. Neurociencias Aplicadas, Barcelona

10032

Columbia University Medical Center, New York

10614

North Estonian Medical Centre Foundation, Tallinn

11217

Taipei Veterans General Hospital, Taipei

13509

Vivantes Humboldt Klinikum, Berlin

14215

State University of New York, Buffalo

15355

Korea University Ansan Hospital, Gyeonggi-do

20877

CBH Health, Gaithersburg

21204

Sheppard Pratt Health System, Baltimore

23561

Taipei Medical University Shuang Ho Hospital, New Taipei City

28034

Hosp. Univ. Ramon Y Cajal, Madrid

28601

Clinical Trials of America, Hickory

28922

Hosp. Univ. Fundacion Alcorcon, Alcorcón

29425

Medical University of South Carolina, Charleston

31008

Clinica Univ. de Navarra, Pamplona

35294

UAB Department of Psychiatry and Behavioral Neurobiology, Birmingham

40201

Chung Shan Medical University Hospital, Taichung

40202

University of Louisville Department of Psychiatry, Louisville

43210

The Ohio State University, Columbus

48013

Hosp. Univ. de Basurto, Bilbao

50417

Tartu University Hospital, Tartu

50586

Hospital Kuala Lumpur, Kuala Lumpur

56000

University Kebangsaan Malaysia Medical Centre, Cheras

59100

University Malaya Medical Centre, Kuala Lumpur

60169

Alexian Behavioral Health Hospital, Hoffman Estates

60528

Universitatsklinikum Frankfurt, Frankfurt am Main

60612

Rush University, Chicago

61469

Chonnam National University Hospital, Gwangju

70115

LSU Health Sciences Center New Orleans, New Orleans

70300

Hospital Tuanku Jaafar, Seremban

71101

Louisiana Clinical Research, Shreveport

75235

University of Texas Southwestern Medical Center, Dallas

79104

Klinik für Psychiatrie und Psychotherapie, Freiburg im Breisgau

85226

Metropolitan Neuro Behavioral Institute, Chandler

92845

Collaborative NeuroScience Network, Garden Grove

06511

Yale University, New Haven

H-9024

Petz Aladar Megyei Oktato Korhaz, Győr

012 07

Fakultna nemocnica s poliklinikou v Ziline, Žilina

02447

Kyung Hee University Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hosp Univ Vall D Hebron, Barcelona

08036

Hosp Clinic de Barcelona, Barcelona

08830

Benito Menni Comp. Asist. Salut Mental, Sant Boi de Llobregat

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03039192 - 54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide | Biotech Hunter | Biotech Hunter