Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00321490
• 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

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Study Completion: 2007-05
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

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

Exclusion Criteria

• Patients (female) must not be pregnant or lactating
• Current or past diagnosis of stroke or transient ischemic attack (TIA).

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; 🇺🇸 Morgantown, West Virginia, United States