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Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

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Trial Profile

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2023

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At a glance

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

Most Recent Events

  • 01 Sep 2023 Results assessing safety and efficacy of lumateperone adjunctive therapy to lithium or valproate in patients with bipolar depression published in the Bipolar Disorders
  • 20 Dec 2021 According to a Intra-Cellular Therapies media release, based on data from study 402 and 404, the U.S. Food and Drug Administration (FDA) has approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
  • 05 Oct 2021 Results assessing the efficacy and safety of lumateperone adjunctive therapy to lithium or valproate in patients with bipolar I or bipolar II disorder experiencing an MDE bipolar depression, presented at the 34th Annual Congress of the European College of Neuropsychopharmacology.

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