Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder

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):
Art Lazarus, MD, Study Director, Affiliation: AstraZeneca

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

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®) as Monotherapy in the Treatment of Patients With MDD

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

Primary outcome: Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary outcome:

Change from randomization to each assessment in the MADRS total score

MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

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

Criteria:

Inclusion Criteria:

- Patient has a documented clinical diagnosis of Major Depressive Disorder.

- Be able to understand and comply with the requirements of the study.

- Able to understand and provide written informed consent

Exclusion Criteria:

- Patients (female) must not be pregnant or lactating

- Current or past diagnosis of stroke or transient ischemic attack (TIA).

Research Site, Little Rock, Arkansas, United States

Research Site, Newport Beach, California, United States

Research Site, Northridge, California, United States

Research Site, Oceanside, California, United States

Research Site, Santa Ana, California, United States

Research Site, Denver, Colorado, United States

Research Site, Norwich, Connecticut, United States

Research Site, Washington, District of Columbia, United States

Research Site, Jacksonville, Florida, United States

Research Site, Winter Park, Florida, United States

Research Site, Smyrna, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Eagle, Idaho, United States

Research Site, Oak Brook, Illinois, United States

Research Site, Wichita, Kansas, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Farmington Hills, Michigan, United States

Research Site, St. Louis, Missouri, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Clementon, New Jersey, United States

Research Site, Cherry Hill, New Jersey, United States

Research Site, Brooklyn, New York, United States

Research Site, New York City, New York, United States

Research Site, Staten Island, New York, United States

Research Site, Raleigh, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Norristown, Pennsylvania, United States

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Bellevue, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Charleston, West Virginia, United States

Research Site, Brown Deer, Wisconsin, United States

Starting date: April 2006
Last updated: July 31, 2007