A multicenter, double-blind, randomized, parallel-group, placebo-controlled, phase III study of the efficacy and safety of quetiapine fumarate (Seroquel SR) sustained-release as monotherapy in adult patients with acute bipolar depression

Trial Profile

A multicenter, double-blind, randomized, parallel-group, placebo-controlled, phase III study of the efficacy and safety of quetiapine fumarate (Seroquel SR) sustained-release as monotherapy in adult patients with acute bipolar depression

Completed
Phase of Trial: Phase III

Latest Information Update: 07 May 2014

At a glance

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

    • 10 Oct 2008 Quetapine [Seroquel] approved by US FDA supported by results from this study.
    • 11 Apr 2008 The first presentation of results from this trial was on 11 Apr 2008 at the Eighth International Review of Bipolar Disorder (IRBD) Conference in Copenhagen, Denmark, reported in an AstraZeneca media release.
    • 02 Nov 2007 Status changed from in progress to completed.
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