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A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects With Schizophrenia and Subjects With Irritability Associated With Autistic Disorder

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Trial Profile

A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects With Schizophrenia and Subjects With Irritability Associated With Autistic Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Lurasidone (Primary)
  • Indications Autistic disorder; Bipolar depression; Bipolar I disorders; Schizophrenia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals

    • Most Recent Events

    • 03 May 2021 According to Sunovion Pharmaceuticals media release, results from this trial presented at The American Psychiatric Association (APA) Annual Meeting
    • 15 Sep 2020 Results of post-hoc analysis evaluating the long-term efficacy of lurasidone in achieving response or remission in children and adolescents with bipolar depression presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
    • 15 Sep 2020 Results of post hoc analysis evaluating the proportion of adolescent patients with schizophrenia who achieved sustained remission and recovery during 2 years of treatment with lurasidone presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
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