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Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107).

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Trial Profile

Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Asenapine (Primary)
  • Indications Bipolar I disorders
  • Focus Therapeutic Use
  • Acronyms Gemini-BP3
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 01 Dec 2015 Results published in the Journal of the American Academy of Child and Adolescent Psychiatry
  • 13 Mar 2015 According to an Actavis media release, based on the results of this trial US FDA has approved its sNDA for asenapine [SAPHRIS] as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients.
  • 02 Oct 2013 The status of the extension study has changed from recruiting to active, no longer recruiting, according to the ClinicalTrials.gov record.

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