Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2019

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top