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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

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

    • Most Recent Events

    • 05 Oct 2021 Results of a post hoc analysis assessing the the effect of baseline mixed depression and the specific subthreshold manic symptoms of sleep disturbance and irritability presented at the 34th Annual Congress of the European College of Neuropsychopharmacology
    • 15 Sep 2020 Results of post hoc analysis from studies in adult and pediatric populations presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
    • 15 Sep 2020 Results (n=537) of post-hoc pooled analysis assessing safety and efficacy of Lurasidone from six double blind, placebo-controlled, 6 weeks clinical studies in adolescents and young adults with schizophrenia presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology

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