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Multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 3 study of the efficacy and safety of quetiapine fumarate and lithium as monotherapy for up to 104 weeks maintenance treatment of bipolar I disorder in adult patients

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Trial Profile

Multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 3 study of the efficacy and safety of quetiapine fumarate and lithium as monotherapy for up to 104 weeks maintenance treatment of bipolar I disorder in adult patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2014

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At a glance

  • Drugs Quetiapine (Primary) ; Lithium
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms SPaRCLe
  • Sponsors AstraZeneca

    • Most Recent Events

    • 12 Jul 2011 New source identified and integrated (European Clinical Trials Database)
    • 12 Jul 2011 Planned end date 22 Jun 2008 added as reported by EudraCT.
    • 01 Apr 2008 Primary endpoint 'Time to disease recurrence' has been met.

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