RecruitingPhase 3NCT07227454

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

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


Sponsor

Janssen Research & Development, LLC

Enrollment

258 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether esketamine (a fast-acting antidepressant given as a nasal spray or infusion) can quickly reduce severe depression and suicidal thinking in children and adolescents who are acutely at risk and require hospitalization. **You may be eligible if...** - You (or your child) have been diagnosed with major depressive disorder - You (or your child) have serious, active suicidal thoughts or urges that require a hospital stay - Depression scores are severely elevated (CDRS-R total score ≥ 58) - Medical tests show you are physically stable enough to participate **You may NOT be eligible if...** - You (or your child) have bipolar disorder, intellectual disability, autism, conduct disorder, or psychosis - You meet criteria for borderline personality disorder - You have a history of seizures - You have allergies or sensitivities to ketamine, esketamine, or midazolam Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine

Esketamine will be administered as intranasal solution.

DRUGMidazolam

Midazolam will be administered as oral solution.

OTHEROral Placebo

Placebo will be administered as oral solution.

OTHERIntranasal Placebo

Intranasal placebo will be administered as nasal solution.


Locations(6)

Peachford Hospital-Atlanta Behavioral Research

Atlanta, Georgia, United States

University of Cincinnati

Cincinnati, Ohio, United States

Instituto Apice

Salvador, Brazil

Centro Integrado Facili

São Bernardo do Campo, Brazil

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07227454


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