A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

Trial Profile

A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Lurasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms Illuminate
  • Sponsors Sunovion Pharmaceuticals
  • Most Recent Events

    • 21 Jul 2017 According to a Sunovion Pharmaceuticals media release, in Jun 2017, Health Canada accepted for review, but has not yet approved, the Supplemental New Drug Submission (SNDS) for the expanded use of LATUDA in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy.
    • 30 Jun 2017 According to a Sunovion Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded use of Latuda (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy.
    • 24 May 2017 Results presented at the 170th Annual Meeting of the American Psychiatric Association
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