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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Once Daily Oral 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 Evaluate the Efficacy and Safety of Once Daily Oral 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

    • Most Recent Events

    • 14 Nov 2019 Results published in the Psychiatry and Clinical Neurosciences
    • 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, full results from this trial will be presented at a scientific meeting in the future.
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