A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder

Study 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.

Conditions

Depressive Disorder, Major

Interventions / Drugs

Esketamine Midazolam Oral Placebo Intranasal Placebo

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment258 participants

Primary Completion—

Lead SponsorJanssen Research & Development, LLC

Data Retrieved2026-04-11 02:55:31.550714+00:00

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