A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania.
Phase of Trial: Phase III
Latest Information Update: 01 Apr 2009
At a glance
- Drugs Quetiapine (Primary)
- Indications Bipolar depression; Bipolar disorders; Bipolar I disorders; Mania
- Focus Therapeutic Use
- Sponsors AstraZeneca
- 10 Oct 2008 Quetiapine 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History