Phase 3 /Seroquel SR Acute Mania Monotherapy - US
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|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.
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): NCT00422123
Show 51 Study Locations
|Study Director:||Catherine Datto, MD||AstraZeneca|
|Study Director:||Larisa Acevedo, Ph.D||AstraZeneca|