A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Dovalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.

Trial Profile

A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Dovalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2017

At a glance

  • Drugs Lurasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms PREVAIL-3
  • Sponsors Sunovion Pharmaceuticals
  • Most Recent Events

    • 21 Oct 2014 Results of post-hoc analysis of lurasidone effects on 6-item MADRS subscale was presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
    • 25 Jun 2013 Results presented at the 11th World Congress of Biological Psychiatry.
    • 30 Aug 2012 New source identified and integrated (Clinical Trials Registry - India; CTRI2011-06-001808).
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