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Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

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Trial Profile

Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2022

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At a glance

  • Drugs Vortioxetine (Primary) ; Fluoxetine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Lundbeck A/S

    • Most Recent Events

    • 11 Jan 2022 Primary endpoint has not been met(Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment) as per Results published in the Journal of the American Academy of Child and Adolescent Psychiatry
    • 11 Jan 2022 Results published in the Journal of the American Academy of Child and Adolescent Psychiatry
    • 08 Aug 2019 Status changed from active, no longer recruiting to completed.

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