A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Start Date
1/8/2026
Completion Date
9/15/2031
Summary
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
Eligibility Criteria
Age Range: 12 years to 17 years
Interventions
Esketamine
Midazolam
Oral Placebo
Intranasal Placebo
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia 30338
United States
Endeavor Health Evanston Hospital
Evanston, Illinois 60201
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Bradley Hospital
East Providence, Rhode Island 02915
United States
John S Dunn Behavioral Sciences Center at UTHealth Houston
Houston, Texas 77021
United States
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, 88811 000
Brazil
Instituto Apice
Salvador, 40170 108
Brazil
Centro Integrado Facili
São Bernardo do Campo, 09726 150
Brazil
Instituto de Pesquisa Pensi Sandra Mutarelli Setubal
São Paulo, 01 227 200
Brazil
Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo
São Paulo, 05403 010
Brazil
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4031
Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9023
Hungary
Szegedi Tudomanyegyetem
Szeged, 6720
Hungary
Presidio Ospedaliero Santa Marta e Santa Venera
Acireale, 95024
Italy
Azienda Ospedaliera G. Brotzu
Cagliari, 09134
Italy
AOU Meyer
Florence, 50134
Italy
Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia
Foggia, 71122
Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, 07100
Italy
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca
Cluj-Napoca, 400658
Romania
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp. Clinic de Barcelona
Barcelona, 08036
Spain
Hosp. Sant Joan de Deu
Esplugues de Llobregat, 08950
Spain
Fundacio Althaia Xarxa Assistencial Universitaria de Manresa
Manresa, 08243
Spain
Hosp. Univ. Central de Asturias
Oviedo, 33011
Spain
Clinica Univ. de Navarra
Pamplona, 31008
Spain
Hosp.Univ.Parc Tauli
Sabadell, 08208
Spain
Mackay Memorial Hospital Tamsui Branch
New Taipei City, 251
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Taipei Veterans General Hospital
Taipei, 112
Taiwan
Tri-Service General Hospital
Taipei, 114
Taiwan