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Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

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Trial Profile

Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2015

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At a glance

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

    • Most Recent Events

    • 26 Jan 2010 Results were published in the Journal of Clinical Psychiatry.
    • 01 Apr 2009 Additional locations Canada, Germany, Poland, Russia reported by ClinicalTrials.gov.
    • 01 Apr 2009 End date 1 May 2007 added from ClinicalTrials.gov.

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