Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder

Completed · Phase 3

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00278941

Run by

AstraZeneca

People needed

3000

Starts

2005-12-01

Expected to finish

2007-08-01

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…

• 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,

You may not qualify if…

• 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

Where it is running

• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Peoria, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Cerritos, California, United States
• Research Site — Costa Mesa, California, United States
• Research Site — El Centro, California, United States
• Research Site — Fresno, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Pasadena, California, United States
• Research Site — Pico Rivera, California, United States
• Research Site — Redlands, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Stanford, California, United States
• Research Site — Torrance, California, United States
• Research Site — Upland, California, United States
• Research Site — Vista, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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