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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Apr 2024

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At a glance

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

    • Most Recent Events

    • 01 May 2023 Status changed from active, no longer recruiting to completed.
    • 30 Mar 2023 Planned primary completion date changed from 5 Apr 2023 to 31 Mar 2023.
    • 28 Feb 2023 Planned primary completion date changed from 21 Apr 2023 to 5 Apr 2023.

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