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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which quetiapine fumarate exerts its antidepressant effects in major depressive disorder?
How does quetiapine fumarate sustained release compare to standard SSRIs in long-term maintenance treatment of MDD?
Are there specific biomarkers that predict response to quetiapine fumarate in patients with treatment-resistant depression?
What are the most common adverse events associated with quetiapine fumarate sustained release in phase III MDD trials?
How does quetiapine fumarate's efficacy in maintenance treatment compare to combination therapies with SNRIs or mirtazapine?
Trial Locations
- Locations (1)
Research Site
🇬🇧Reading, United Kingdom
Research Site🇬🇧Reading, United Kingdom