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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
2026-03-13
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 (2)
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia, United States
University of Cincinnati
Cincinnati, Ohio, United States