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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Esketamine (Primary) ; Antidepressants
  • Indications Major depressive disorder; Suicidal ideation
  • Focus Registrational; Therapeutic Use
  • Acronyms Aspire II
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 20 Aug 2021 Results of a post hoc analyses of pooled data (NCT03039192, NCT03097133) changes from baseline at 24 hours after the first dose in Montgomery Asberg Depression Rating Scale total score and Clinical Global Impression-Severity of Suicidality Revised, in the full cohort and in subgroups published in the Journal of Clinical Psychopharmacology
    • 08 Feb 2021 According to a Janssen media release, the European Commission (EC) has authorized the expanded use of SPRAVATO (esketamine nasal spray) co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency, based on results from two Phase 3 ASPIRE studies (ASPIRE I and II).
    • 11 Dec 2020 According to a Janssen media release, positive opinion is based on results from two Phase 3 ASPIRE studies (ASPIRE I and II).

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