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

NCT07227454

This study is recruiting at 10 US sites in 10 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Depressive Disorder, Major

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
12 to 17 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Janssen Research & Development, LLC
Last updated on ClinicalTrials.gov
September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • University of Alabama at Birmingham · Birmingham, AL

District of Columbia · 1

  • Children's National Medical Center · Washington D.C., DC

Georgia · 1

  • Peachford Hospital-Atlanta Behavioral Research · Atlanta, GA

Illinois · 1

  • Endeavor Health Evanston Hospital · Evanston, IL

Maryland · 1

  • Johns Hopkins University · Baltimore, MD

Massachusetts · 1

  • Boston Childrens Hospital · Boston, MA

Minnesota · 1

  • Mayo Clinic · Rochester, MN

Ohio · 1

  • University of Cincinnati · Cincinnati, OH

Rhode Island · 1

  • Bradley Hospital · East Providence, RI

Texas · 1

  • John S Dunn Behavioral Sciences Center at UTHealth Houston · Houston, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.