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A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Sponsor: Janssen Research & Development, LLC
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.
Official title: A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
258
Start Date
2026-01-08
Completion Date
2031-09-15
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Esketamine
Esketamine will be administered as intranasal solution.
Midazolam
Midazolam will be administered as oral solution.
Oral Placebo
Placebo will be administered as oral solution.
Intranasal Placebo
Intranasal placebo will be administered as nasal solution.
Locations (30)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia, United States
Endeavor Health Evanston Hospital
Evanston, Illinois, United States
University of Cincinnati
Cincinnati, Ohio, United States
Bradley Hospital
East Providence, Rhode Island, United States
John S Dunn Behavioral Sciences Center at UTHealth Houston
Houston, Texas, United States
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, Brazil
Instituto Apice
Salvador, Brazil
Centro Integrado Facili
São Bernardo do Campo, Brazil
Instituto de Pesquisa Pensi Sandra Mutarelli Setubal
São Paulo, Brazil
Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo
São Paulo, Brazil
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary
Szegedi Tudomanyegyetem
Szeged, Hungary
Presidio Ospedaliero Santa Marta e Santa Venera
Acireale, Italy
AOU Meyer
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia
Foggia, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy
Hosp. Clinic de Barcelona
Barcelona, Spain
Hosp. Sant Joan de Deu
Esplugues de Llobregat, Spain
Fundacio Althaia Xarxa Assistencial Universitaria de Manresa
Manresa, Spain
Hosp. Univ. Central de Asturias
Oviedo, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp.Univ.Parc Tauli
Sabadell, Spain
Mackay Memorial Hospital Tamsui Branch
New Taipei City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan