Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00326144
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
- Patient is able to provide written informed consent before beginning any study related procedures
- Patient has a documented clinical diagnosis of major depressive disorder
- Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
Exclusion Criteria
- Patients with a history of non-compliance as judged by the study investigator
- Patients with a known lack of response to previous treatment with quetiapine
- Patients who have participated in a clinical trial within 4 weeks of randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score
- Secondary Outcome Measures
Name Time Method To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo
Trial Locations
- Locations (2)
Research Site
🇺🇸Houston, Texas, United States
Research SIte
🇺🇸Staten Island, New York, United States