A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD).

Trial Profile

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects With Major Depressive Disorder (MDD).

Completed
Phase of Trial: Phase II

Latest Information Update: 02 May 2018

At a glance

  • Drugs Vortioxetine (Primary) ; Duloxetine
  • Indications Cognition disorders; Major depressive disorder
  • Focus Therapeutic Use
  • Acronyms CONNECT
  • Sponsors Takeda
  • 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.
    • 12 Mar 2018 Results of post hoc subgroup analysis assessing effect of vortioxetine on functional capacity in demographic and clinical subgroups of patients with major depressive disorder published in the International Journal of Neuropsychopharmacology
    • 04 Feb 2016 According to Lundbeck media release, FDA Psychopharmacologic Drug Advisory Committee supports the effectiveness of Brintellix and reviewed data from this trial.
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