Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant 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 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.

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 SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment (PEARL STUDY)

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

Primary outcome: To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS

Secondary outcome:

To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone

To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone

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, El Centro, California, United States

Research Site, Oceanside, California, United States

Research Site, San Diego, California, United States

Research Site, IRVINE, California, United States

Research Site, Pueblo, Colorado, United States

Research Site, Hialeah, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Coral Springs, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, GAINSVILLE, Florida, United States

Research Site, MIAMI, Florida, United States

Research Site, DELAND, 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, GLEN BURNIE, Maryland, United States

Research Site, Springfield, Massachusetts, United States

Research Site, Braintree, Massachusetts, United States

Research Site, Clinton Township, Michigan, United States

Research Site, Kalamazoo, Michigan, United States

Research Site, Royal Oak, Michigan, United States

Research Site, St. Louis, Missouri, United States

Research Site, ST CHARLES, Missouri, United States

Research Site, CHERRY HILL, New Jersey, United States

Research Site, CLEMENTON, New Jersey, United States

Research Site, New York, New York, United States

Research Site, Rochester, New York, United States

Research Site, Staten Island, New York, United States

Research Site, CEDARHURST, New York, United States

Research Site, OLEAN, New York, United States

Research Site, TOLEDO, Ohio, United States

Research Site, BEECHWOOD, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Norman, Oklahoma, United States

Research Site, PHILADELPHIA, Pennsylvania, United States

Research Site, LINCOLN, Rhode Island, United States

Research Site, Columbia, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Houston, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, FRIENDSWOOD, Texas, United States

Research SIte, WICHITA FALLS, Texas, United States

Research Site, SALT LAKE CITY, Utah, United States

Research Site, Richmond, Virginia, United States

Research Site, ARLINGTON, Virginia, United States

Research Site, BELLEVUE, Washington, United States

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