Phase 3 /Seroquel SR Acute Mania 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 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.
|Affective Psychosis, Bipolar Manic Disorder Manic-Depressive Psychosis Mania Manic State 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®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422123
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|Study Director:||Catherine Datto, MD||AstraZeneca|
|Study Director:||Larisa Acevedo, Ph.D||AstraZeneca|