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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2022

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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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