Clinical Trial

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

Study acronym: AVENUE
Recruiting Phase 3
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 30 -> 35 locations 2026-08-01
notable Trial sites expanded: 27 -> 30 locations 2026-07-07
notable Trial sites expanded: 9 -> 27 locations 2026-06-06
notable Trial sites expanded: 6 -> 9 locations 2026-05-09
notable Trial sites expanded: 2 -> 6 locations 2026-04-14
Trial Details
NCT Number NCT07227454
Lead Sponsor Janssen Research & Development, LLC
Conditions Depressive Disorder, Major
Enrollment 258 participants
Start Date 2026-01-08
Primary Completion 2031-04-09 (estimated)
Study Completion 2031-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-31