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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 12 Aug 2024

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At a glance

  • Drugs Brexpiprazole (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical

    • Most Recent Events

    • 22 Dec 2023 According to an Otsuka Pharmaceutical media release, based on results from this trial, the company has obtained approval in Japan for an additional indication for Rexulti (generic name: brexpiprazole) for the treatment of Major Depressive Disorder (Administration should be limited to patients who showed an inadequate response to existing antidepressant therapy).
    • 30 Jan 2023 According to an Otsuka Pharmaceutical media release, the company has filed an application in Japan for an additional indication for Rexulti (generic name: brexpiprazole) for the treatment of Major Depressive Disorder (Administration should be limited to patients who showed an inadequate response to existing antidepressant therapy).
    • 12 Sep 2022 According to an Otsuka Pharmaceutical media release, additional analysis of the trial results is planned to further interpret the efficacy and safety of brexpiprazole.

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