Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00320268
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- Patient has a documented clinical diagnosis of Major Depressive Disorder.
- Be able to understand and comply with the requirements of the study.
- Able to understand and provide written informed consent
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Exclusion Criteria
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
- Secondary Outcome Measures
Name Time Method Change from randomization to each assessment in the MADRS total score MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
Trial Locations
- Locations (1)
Research Site
🇺🇸Brown Deer, Wisconsin, United States