52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

Trial Profile

52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Nov 2017

At a glance

  • Drugs Aripiprazole (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 02 Nov 2017 According to an Otsuka Pharmaceutical media release, Health Canada has issued a Notice of Compliance for ABILIFY MAINTENA (aripiprazole for prolonged release injectable suspension), approving a new indication for the maintenance monotherapy treatment of bipolar I disorder in adult patients.
    • 28 Jul 2017 According to a Lundbeck A/S media release, Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the US FDA for the maintenance monotherapy treatment of bipolar I disorder (BP I) in adults. The results of this trial supported the regulatory approval.
    • 31 Jan 2017 Results assessing efficacy and safety published in the Journal of Clinical Psychiatry.
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