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A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Who Are Assessed to be at Imminent Risk for Suicide

Trial Profile

A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Who Are Assessed to be at Imminent Risk for Suicide

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Apr 2019

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At a glance

  • Drugs Esketamine (Primary)
  • Indications Major depressive disorder
  • Focus Proof of concept; Therapeutic Use
  • Acronyms ESKETINSUI2001
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 16 Apr 2018 Results presented in a Janssen Pharmaceutical Companies media release.
    • 16 Apr 2018 Primary endpoint (Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Hour 4 Post-administration of Study Treatment on Day 1) has been met as per the results published in the American Journal of Psychiatry.
    • 16 Apr 2018 Results published in the American Journal of Psychiatry
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