Official Title: “A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder”

The purpose of this study is to determine safety & efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo & to evaluate quality of sleep, overall quality of life, and effect, if any, on anxiety and satisfaction PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Fumarate Sustained Release

Primary Measures

• To evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to a depressed event in patients with Major Depressive Disorder (MDD)

Secondary Measures

• Evaluate quetiapine SR compared to placebo on health related quality of life.

Inclusion Criteria:

• Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major
• Depressive Disorder,
• Single Episode, or 296.3x Major Depressive Disorder,

Exclusion Criteria:

• Patients with a DSM-IV Axis I disorder other than MDD w/in 6 months of enrollment,
• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patients current psychiatric status.
• Patients whose current episode of depression>12 months or <4 weeks from enrollment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Seroquel Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00278941

Study ID Number: D1448C00005

ClinicalTrials.gov Identifier: NCT00278941

Health Authority: United States: Food and Drug Administration

AstraZeneca Clinical Trial Information - Outside US