A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety 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 Adult Subjects 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 in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide

Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2018

At a glance

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

    • 15 Jun 2018 Planned End Date changed from 24 Sep 2019 to 31 Jul 2019.
    • 15 Jun 2018 Planned primary completion date changed from 23 Sep 2019 to 29 Jul 2019.
    • 21 Jun 2017 Status changed from not yet recruiting to recruiting.
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