drugset / Trial / NCT07227454

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

NCT07227454

Phase 3 Recruiting 258 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-01-08
Primary completion
2031-04-09
Completion
2031-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 56 mg Intranasal
Subject Esketamine Other / unclassified 84 mg Intranasal
Comparator Midazolam Small molecule 0.0625 mg/kg Oral