A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Brexpiprazole (Primary) ; Antidepressants
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms Polaris
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 01 Sep 2015 Results of post hoc analysis presented at the 28th Annual Congress of the European College of Neuropsychopharmacology
    • 10 Jul 2015 The U.S. FDA has approved brexpiprazole [Rexulti] as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD) and as a treatment for adults with schizophrenia. The approval is supported by four completed phase III trials-two trials as adjunctive therapy to antidepressants in patients with MDD and two trials in patients with schizophrenia.
    • 20 May 2015 Pooled analysis results presented at the 168th Annual Meeting of the American Psychiatric Association.
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