Phase III/Seroquel SR Bipolar Depression Monotherapy - US
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
|Affective Psychosis, Bipolar Depression, Bipolar Manic-Depressive Psychosis Psychoses, Manic-Depressive||Drug: Quetiapine fumarate (Seroquel) SR||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- Change from baseline in depression symptoms by final visit as measured by the MADRS total score
- Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
|Study Start Date:||December 2006|
|Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422214
Show 54 Study Locations
|Study Director:||Catherine Datto, MD||AstraZeneca|
|Study Director:||Larisa Acevedo, Ph.D||AstraZeneca|