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A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression.

Trial Profile

A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone 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)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms PREVAIL-2
  • Sponsors 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
  • 18 Oct 2022 Results of post-hoc analysis evaluating response on symptom severity measures, as well as combined response to multiple measures, including symptom severity, function, and quality of life, presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
  • 01 Sep 2022 Results of post-hoc analysis assessing impact of lurasidone monotherapy on health-related quality of life in adults with bipolar depression were published in the Current Medical Research and Opinion.

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