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A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder

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Trial Profile

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Dec 2021

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At a glance

  • Drugs Cariprazine (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Forest Laboratories

    • Most Recent Events

    • 05 Oct 2021 Results assessing NCT00488618; NCT01058096; NCT01058668;NCT01396447; NCT02670538 and NCT02670551 assessing efficacy of cariprazine in manic, depressive, and cognitive symptoms in bipolar I disorder in light of its receptor profile, presented at the 34th Annual Congress of the European College of Neuropsychopharmacology
    • 09 May 2018 Results (n=1037) of post hoc analysis of pooled data from 3 studies (NCT00488618, NCT01058096 and NCT01058668) presented at the 171st Annual Meeting of the American Psychiatric Association
    • 09 Nov 2017 Results of pooled data from 6 trial (RGH-MD-31, RGH-MD-32, RGH-MD-33, RGH-MD-04, RGH-MD-05 and RGH-MD-16) assessing global improvement with cariprazine in the treatment of biploar I disorder and schizophrenia, were published in the International Journal of Clinical Practice.

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