Phase 3 /Seroquel SR Acute Mania Monotherapy - US
|ClinicalTrials.gov Identifier: NCT00422123|
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 Mania for 3 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 Manic Disorder Manic-Depressive Psychosis Mania Manic State Psychoses, Manic-Depressive||Drug: Quetiapine fumarate (Seroquel) SR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||447 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®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania|
|Study Start Date :||January 2007|
|Actual Study Completion Date :||July 2007|
- Change from baseline to final visit in the YMRS total score
- Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422123
Show 51 Study Locations
|Study Director:||Catherine Datto, MD||AstraZeneca|
|Study Director:||Larisa Acevedo, Ph.D||AstraZeneca|