A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

Trial Profile

A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

Recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Aug 2018

At a glance

  • Drugs Esketamine (Primary) ; Midazolam
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 31 May 2018 Planned End Date changed from 4 Feb 2022 to 7 Feb 2022.
    • 04 May 2018 Status changed from suspended to recruiting.
    • 05 Apr 2018 Status changed from recruiting to suspended.
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