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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2013

At a glance

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

    • 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.
    • 14 Dec 2007 Status changed from inprogress to completed.
    • 16 Oct 2005 New trial record.
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