Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (ONYX)
|ClinicalTrials.gov Identifier: NCT00351910|
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : January 26, 2011
To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with 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 Drug: Amitriptyline Drug: Bupropion Drug: Citalopram Drug: Duloxetine Drug: Escitalopram Drug: Fluoxetine Drug: Paroxetine Drug: Sertraline Drug: Venlafaxine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||April 2007|
- To evaluate the efficacy of quetiapine fumarate sustained release
- (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
- If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351910
Show 74 Study Locations
|Study Director:||Seroquel Medical Science Director, MD||AstraZeneca|