Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00326105
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-16
• Study Completion: 2007-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patient is able to provide written informed consent before beginning any study related procedures
• Patient has a documented clinical diagnosis of major depressive disorder
• Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Read More

Exclusion Criteria

• Patients with a history of non-compliance as judged by the study investigator
• Patients with a known lack of response to previous treatment with quetiapine
• Patients who have participated in a clinical trial within 4 weeks of randomization

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS

Secondary Outcome Measures

Name	Time	Method
To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone
To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone

Trial Locations

Locations (2)

Research Site; 🇺🇸 Bellevue, Washington, United States

Research SIte; 🇺🇸 Wichita Falls, Texas, United States