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.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2016

At a glance

  • Drugs Lurasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms PREVAIL-2
  • Sponsors Sunovion Pharmaceuticals
  • Most Recent Events

    • 01 Oct 2016 Results of a pooled post-hoc analysis in the older adult subgroup of patients (n=142) assessing efficacy of lurasidone from NCT00868699 and NCT00868452 studies published in the Journal of Clinical Psychiatry.
    • 22 Dec 2015 Results of pooled analysis of two randomized, 6-week trials (NCT00868452 and NCT00868699) published in the Clinical Therapeutics.
    • 01 Sep 2015 Results (predictor of short-term response) presented at the 28th Annual Congress of the European College of Neuropsychopharmacology
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