Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Summary

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

Timeline

Start

2017-10-05

Primary completion

2023-03-31

Completion

2023-03-31

Outcome

Met primary endpoint

paper Pooled esketamine doses (56 and 84 mg) showed superiority over midazolam in reducing CDRS-R total score at 24 hours post first dose PMID 40058488 ↗

paper The primary efficacy end point of the study was met for the pooled esketamine doses (56 and 84 mg). PMID 40058488 ↗

registry analysis (superiority test); Placebo + Midazolam + SOC vs Pooled Esketamine 56 mg + Esketamine 84 mg; p = 0.037 NCT03185819 ↗

Publications

• Kosik-Gonzalez C, Fu DJ, Chen LN, Lane R, Bloch MH, DelBello M, Moreno C, Drevets WC, Canuso CM. Effect of Esketamine on Depressive Symptoms in Adolescents With Major Depressive Disorder at Imminent Suicide Risk: A Randomized Psychoactive-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):42-55. doi: 10.1016/j.jaac.2025.02.015. Epub 2025 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esketamine	Other / unclassified	28 mg	Intranasal
Subject	Esketamine	Other / unclassified	56 mg	Intranasal
Subject	Esketamine	Other / unclassified	84 mg	Intranasal
Comparator	Midazolam	Small molecule	0.125 mg/kg	Oral

Indications