A randomized, double-blind, placebo-controlled, parallel-group, dose-response, multicenter study to evaluate the efficacy and safety of three fixed doses of extended-release paliperidone in the treatment of subjects with acute manic and mixed episodes associated with bipolar I disorder.

Trial Profile

A randomized, double-blind, placebo-controlled, parallel-group, dose-response, multicenter study to evaluate the efficacy and safety of three fixed doses of extended-release paliperidone in the treatment of subjects with acute manic and mixed episodes associated with bipolar I disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jan 2012

At a glance

  • Drugs Paliperidone (Primary)
  • Indications Bipolar I disorders
  • Focus Therapeutic Use
  • Most Recent Events

    • 21 May 2009 Primary endpoint 'Young-Mania-Rating-Scale' has been met (1132624).
    • 21 May 2009 Primary endpoint results presented at the 162nd Annual Meeting of the American Psychiatric Association
    • 20 Mar 2008 Status changed from in progress to completed based on information from the ClinicalTrials.gov site.
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