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A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384).

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Trial Profile

A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Asenapine (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Actavis; Forest Laboratories; Merck Sharp & Dohme

Most Recent Events

  • 26 Sep 2017 According to results published in the American Journal of Psychiatry, study protocol was amended with relapse rate assumptions updated to 34% for the placebo group (hazard ratio=0.45) and to 17% for the asenapine group.
  • 26 Sep 2017 Primary endpoint (Time to recurrence of any mood event during the Double-Blind Treatment Period) has been met, according to results published in the American Journal of Psychiatry.
  • 26 Sep 2017 Results published in the American Journal of Psychiatry.

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