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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression

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Trial Profile

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Lurasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms ELEVATE
  • Sponsors Sumitomo Dainippon Pharma

    • Most Recent Events

    • 15 Sep 2020 Results of two randomized study (NCT00868699 and NCT01986101) assessing effect on core depressive symptoms, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology.
    • 22 Aug 2020 Primary endpoint ((MADRS)-80 - 120 mg/day group) has not been met, as per Results published in the Psychiatry and Clinical Neurosciences
    • 22 Aug 2020 Results published in the Psychiatry and Clinical Neurosciences

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