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A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

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Trial Profile

A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Lurasidone (Primary) ; Lithium; Valproate
  • Indications Bipolar I disorders
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms PREVAIL-1
  • Sponsors Dainippon Sumitomo Pharma; Sunovion Pharmaceuticals

    • Most Recent Events

    • 07 Jun 2023 Results of post hoc, pooled analysis NCT00868699 and NCT00868452, assessing the effects of lurasidone on anxiety symptoms and sleep disruption, and their moderating and mediating roles on treatment response in bipolar depression, analysis published in the Journal of Clinical Psychiatry
    • 05 Oct 2021 Results of post-hoc pooled analysis relationships between symptoms of anxiety and depression while controlling for the moderating effects of the specific subthreshold manic symptom of sleep disturbance (decreased need for sleep), and their implications for treatment response to lurasidone in patients with bipolar depression in two studies (Prevail-1 & Prevail-2) presented at the 34th Annual Congress of the European College of Neuropsychopharmacology.
    • 03 May 2021 Acccording to the Sunovion Pharmaceuticals media release, results of post-hoc pooled analysis from two placebo-controlled studies on lurasidone as monotherapy and as adjunctive therapy with lithium or valproate in adult patients with bipolar depression presented at the American Psychiatric Association Annual Meeting
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