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

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00326105

Run by

AstraZeneca

People needed

450

Starts

2006-04-01

Expected to finish

2007-07-01

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 — El Centro, California, United States
• Research Site — Irvine, California, United States
• Research Site — Oceanside, California, United States
• Research Site — San Diego, California, United States
• Research Site — Pueblo, Colorado, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Gainsville, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Roswell, Georgia, United States
• Research Site — Hoffman Estates, Illinois, United States
• Research Site — Naperville, Illinois, United States
• Research Site — Oak Brook, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Lafayette, Indiana, United States
• Research Site — Valparaiso, Indiana, United States
• Research Site — Prairie Village, Kansas, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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