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RECRUITING
NCT07227454
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

258

Start Date

2026-01-08

Completion Date

2031-09-15

Last Updated

2026-03-13

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 (2)

Peachford Hospital-Atlanta Behavioral Research

Atlanta, Georgia, United States

University of Cincinnati

Cincinnati, Ohio, United States