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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2026

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At a glance

  • Drugs Esketamine (Primary) ; Midazolam
  • Indications Major depressive disorder; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms AVENUE
  • Sponsors Janssen Research & Development

Most Recent Events

  • 16 Jan 2026 Status changed from not yet recruiting to recruiting.
  • 10 Dec 2025 Planned initiation date changed from 20 Nov 2025 to 24 Feb 2026.
  • 18 Nov 2025 New trial record

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