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Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of Lu AA21004 [Vortioxetine] on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)

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Trial Profile

Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of Lu AA21004 [Vortioxetine] on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2018

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At a glance

  • Drugs Vortioxetine (Primary)
  • Indications Major depressive disorder
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms Cognition PoC; FOCUS
  • Sponsors Lundbeck A/S

    • Most Recent Events

    • 02 May 2018 According to a Takeda Pharma media release, the US FDA has approved a supplemental new drug application for vortioxetine to include new data from the FOCUS and CONNECT studies in the labelling.
    • 25 Oct 2016 Results of a post-hoc analysis assessing the effect of vortioxetine on cognitive functioning and depressive symptoms from 5 studies, published in the Journal of Clinical Psychiatry.
    • 26 May 2016 Results (post hoc analyses) assessing vortioxetine efficacy on cognitive dysfunction in depression published in the International Journal of Neuropsychopharmacology.

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