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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Key facts

Study ID

NCT00326144

Run by

AstraZeneca

People needed

310

Starts

2006-04-01

Expected to finish

2007-05-01

Last updated by the study team

2009-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — El Centro, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — National City, California, United States
• Research Site — Riverside, California, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Wilmington, Delaware, United States
• Research Site — Altamonte Springs, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Maitland, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Roswell, Georgia, United States
• Research Site — Naperville, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Lafayette, Indiana, United States
• Research Site — Owensboro, Kentucky, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Braintree, Massachusetts, United States
• Research Site — Cambridge, Massachusetts, United States
• Research Site — Pittsfield, Massachusetts, United States
• Research Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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