NCT00320268CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 600
- Locations
- 37
- Primary Endpoint
- Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Study Overview
Brief Summary
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Patients (female) must not be pregnant or lactating
- •Current or past diagnosis of stroke or transient ischemic attack (TIA).
Outcomes
Primary Outcomes
Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary Outcomes
- MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6
- Change from randomization to each assessment in the MADRS total score
Investigators
Study Sites (37)
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