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

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Jul 2017

At a glance

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

    • 14 Jul 2017 Planned End Date changed from 21 Oct 2021 to 4 Feb 2022.
    • 14 Jul 2017 Planned initiation date changed from 14 Aug 2017 to 29 Sep 2017.
    • 19 Jun 2017 New trial record
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