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).

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

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

    • 17 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 26 May 2015 Planned number of patients changed from 550 to 561 as reported by ClinicalTrials.gov.
    • 21 Jul 2014 Planned primary completion date changed from 1 Jun 2015 to 1 May 2015 as reported by ClinicalTrials.gov.
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