Phase III/Seroquel SR Bipolar Depression Monotherapy - US
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|ClinicalTrials.gov Identifier: NCT00422214|
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : March 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Affective Psychosis, Bipolar Depression, Bipolar Manic-Depressive Psychosis Psychoses, Manic-Depressive||Drug: Quetiapine fumarate (Seroquel) SR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||June 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422214
Show 54 Study Locations
|Study Director:||Catherine Datto, MD||AstraZeneca|
|Study Director:||Larisa Acevedo, Ph.D||AstraZeneca|