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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2023

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Bipolar depression; Bipolar I disorders; Bipolar II disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies

    • Most Recent Events

    • 24 Apr 2023 Results of post-hoc analysis assessing efficacy of lumateperone 42 mg in patients with bipolar I or bipolar II disorder and experiencing a major depressive episode (MDE) stratified by the presence of mixed features, published in the Journal of Clinical Psychiatry.
    • 12 Jan 2023 Results of pre-specified secondary and post-hoc analysis assessing efficacy of lumateperone on symptoms of depression in bipolar I and bipolar II disorder, published in the European Neuropsychopharmacology.
    • 18 Oct 2022 Results of post hoc analysis investigating the shift in severity of depression symptoms, presented at the 35th Annual Congress of the European College of Neuropsychopharmacology

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