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A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

Trial Profile

A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Ziprasidone (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer; Viatris Inc
  • Most Recent Events

    • 01 Apr 2022 Primary endpoint change from baseline in Young Mania Rating Scale (YMRS) to week 4 has been met, according to results published in the Journal of Child and Adolescent Psychopharmacology.
    • 01 Apr 2022 Results published in the Journal of Child and Adolescent Psychopharmacology
    • 21 Jul 2020 Status changed from recruiting to discontinued.
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