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A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone

Trial Profile

A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2022

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At a glance

  • Drugs Cariprazine (Primary) ; Antidepressants
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie; Allergan
  • Most Recent Events

    • 16 Dec 2022 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has approved VRAYLAR (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
    • 10 Jun 2022 Results presented at the 175th Annual Meeting of the American Psychiatric Association
    • 23 May 2022 According to an AbbVie media release, FDA's decision on sNDA is expected by year-end.
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