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

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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

Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score

Secondary outcome:

To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo

To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

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

Research Site, Phoenix, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, El Centro, California, United States

Research Site, National City, California, United States

Research Site, Anaheim, California, United States

Research Site, GARDEN GROVE, 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, Roswell, Georgia, United States

Research Site, DECATUR, Georgia, United States

Research Site, NAPERVILLE, Illinois, United States

Research Site, Lafayette, Indiana, United States

Research Site, Indianapolis, 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

Research Site, St. Louis, Missouri, United States

Research SIte, STATEN ISLAND, New York, United States

Research Site, Avon Lake, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, MEMPHIS, Tennessee, United States

Research Site, DeSoto, Texas, United States

Research Site, HOUSTON, Texas, United States

Starting date: April 2006
Ending date: June 2007
Last updated: November 2, 2007