Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (AMBER)
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|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|
|Actual 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
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): NCT00351169
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|Study Director:||Willie Earley, MD||AstraZeneca|