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A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients

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Trial Profile

A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy and Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2021

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At a glance

  • Drugs Quetiapine (Primary)
  • Indications Bipolar I disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 01 Aug 2008 Results published in Journal of Affective Disorders.
    • 14 May 2008 FDA approval for use of quetiapine for the maintenance treatment of patients with bipolar I disorders, as adjunct to lithium or valproate semisodium, based on this and another phase III trial.
    • 10 Jan 2008 Status change from in progress to completed.
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