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

NCT07227454 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2031-04-09
Completion
2031-09-15
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Hungary
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227454 on ClinicalTrials.gov