Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00351169
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
Exclusion Criteria
- Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
- Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment
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 major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.
- Secondary Outcome Measures
Name Time Method If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo
Trial Locations
- Locations (1)
Research Site
🇪🇸Zamora, Spain