Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder
Overview
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Full Title of Study: “A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
Interventions
- Drug: Quetiapine fumarate
- Drug: Duloxetine
Clinical Trial Outcome Measures
Primary Measures
- Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Secondary Measures
- 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
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- AstraZeneca
- Overall Official(s)
- Art Lazarus, MD, Study Director, AstraZeneca
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