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

Completed
Phase of Trial: Phase II

Latest Information Update: 16 Aug 2016

At a glance

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

    • 16 Aug 2016 Preliminary clinical evidence from this trial supported the Breakthrough Therapy Designation for major depressive disorder with imminent risk for suicide, as reported by Janssen Research & Development media release.
    • 01 May 2016 Results from this trial presented at the Society of Biological Psychiatry 71st Annual Scientific Meeting, as reported by Janssen Research & Development media release.
    • 18 Mar 2016 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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