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

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

Age range

12–17 years

Sex

All

Healthy volunteers

No

Interventions

• 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.

Locations (9)