Randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of flexibly-dosed extended-release paliperidone compared with flexibly-dosed quetiapine and placebo in the treatment of acute manic and mixed episodes in bipolar disorder.

Trial Profile

Randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of flexibly-dosed extended-release paliperidone compared with flexibly-dosed quetiapine and placebo in the treatment of acute manic and mixed episodes in bipolar disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jul 2014

At a glance

  • Drugs Paliperidone (Primary) ; Quetiapine
  • Indications Bipolar I disorders
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 05 Oct 2008 Additional trial identifier R076477BIM3002 added as reported by ClinicalTrials.gov.
    • 05 Oct 2008 Planned number of patients changed from 475 to 493 as reported by ClinicalTrials.gov.
    • 21 Nov 2006 New trial record.
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