Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (AMBER)
|ClinicalTrials.gov Identifier: NCT00351169|
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : December 22, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Quetiapine SR Drug: Escitalopram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2006|
|Study Completion Date :||June 2007|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351169
Show 42 Study Locations
|Study Director:||Willie Earley, MD||AstraZeneca|