Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (AMBER)
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Major Depressive Disorder
Drug: Quetiapine SR
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder|
- To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
- If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo
|Study Start Date:||May 2006|
|Study Completion Date:||June 2007|
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|Study Director:||Willie Earley, MD||AstraZeneca|