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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose — Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2)
  The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5 point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged from 17 (normal) to 113 (severe depression). Higher score indicated more severe depression and worse outcome.

Trial sites (44)

+ 4 more sites — see the full list on the official registry below.

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