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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History