NCT07227454

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Esketamine	Esketamine will be administered as intranasal solution.
DRUG	Midazolam	Midazolam will be administered as oral solution.
OTHER	Oral Placebo	Placebo will be administered as oral solution.
OTHER	Intranasal Placebo	Intranasal placebo will be administered as nasal solution.

Timeline

• Start date: 2026-01-08
• Primary completion: 2031-04-09
• Completion: 2031-09-15
• First posted: 2025-11-12
• Last updated: 2026-04-13

Locations

6 sites across 3 countries: United States, Brazil, Taiwan

Regulatory

• FDA-regulated drug study