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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2022

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At a glance

  • Drugs Vortioxetine (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda; Takeda Global Research and Development Center

    • Most Recent Events

    • 20 Sep 2019 According to a Takeda media release, based on the data from the pivotal phase III study (NCT02389816) along with data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147), the Ministry of Health, Labour and Welfare (MHLW) has aaproved Trintellix (vortioxetine) for the treatment of Major Depressive Disorder in Adults.
    • 28 Sep 2018 According to a Takeda media release, based on the data from the pivotal phase III study (NCT02389816) along with data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147), Lundbeck and its partner Takeda has submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults.
    • 12 Nov 2017 Results of a short-term study (NCT01355081) and its long-term extension study (NCT01395147), published in the Psychiatry and Clinical Neurosciences Journal.

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