Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00278941
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine safety \& efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo \& to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction 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
- 3000
Inclusion Criteria
- Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder,
- Single Episode, or 296.3x Major Depressive Disorder,
Exclusion Criteria
- Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
- Patients whose current episode of depression>12 months or <4 weeks from enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)
- Secondary Outcome Measures
Name Time Method Evaluate quetiapine SR compared to placebo on health related quality of life.
Trial Locations
- Locations (1)
Research Site
🇬🇧Reading, United Kingdom