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

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: 14 Aug 2019

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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

    • 31 Jul 2019 According to a Sumitomo Dainippon Pharma media release, the company has submitted a new drug application for approval of manufacturing and marketing for lurasidone hydrochloride in Japan for the treatment of schizophrenia and bipolar depression, based on the data from this and other study (JEWEL).
    • 26 Jul 2017 Status changed from active, no longer recruiting to completed.
    • 09 Jun 2017 Data from this trial published in a Sumitomo Dainippon Pharma Media Release.
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