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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Aripiprazole as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Dec 2019

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At a glance

  • Drugs Aripiprazole (Primary) ; Antidepressants
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 24 Mar 2014 A post hoc analysis of pooled data from 3 phase 3 studies, was published in Journal of Affective Disorders.
    • 06 Jun 2013 Based on results of this study, and CN138-163 and CN138-165, aripiprazole has received approval from Health Canada as adjunctive treatment of major depressive disorder, according to a Bristol-Myers Squibb media release.
    • 24 Aug 2010 Results of a pooled analysis [trial profiles 700004743 and 700011903] on suicidal ideation resulting from aripiprazole therapy published in the Journal of Clinical Psychiatry.

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