Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Quetiapine Fumarate (Drug); Escitalopram oxylate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Anders Neijber, MD, Study Director, Affiliation: AstraZeneca

The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder

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

Primary outcome: Change from randomization in the HAM-A total score at Day 57

Secondary outcome: Change from randomization in CGI-S score at Day 57

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

Criteria:

Inclusion Criteria:

- Patient has a documented clinical diagnosis of Generalized Anxiety 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, Birmingham, Alabama, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, San Diego, California, United States

Research Site, Beverly Hills, California, United States

Research Site, Sherman Oaks, California, United States

Research Site, Wildomar, California, United States

Research Site, La Mesa, California, United States

Research Site, Orange, California, United States

Research Site, Pasadena, California, United States

Research Site, Upland, California, United States

Research Site, Burbank, California, United States

Research Site, New Britain, Connecticut, United States

Research Site, Washington, District of Columbia, United States

Research Site, Bradenton, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, West Palm Beach, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, Boca Raton, Florida, United States

Research Site, Deland, Florida, United States

Research Site, Fort Lauderdale, Florida, United States

Research Site, FT MYERS, Florida, United States

Research Site, Maitland, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Edwardsville, Illinois, United States

Research Site, Merrillville, Indiana, United States

Research Site, Terre Haute, Indiana, United States

Research Site, NEWTON, Kansas, United States

Research Site, PRAIRIE VILLAGE, Kansas, United States

Research Site, OWENSBORO, Kentucky, United States

Research Site, Lake Charles, Louisiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Haverhill, Massachusetts, United States

Research Site, Boston, Massachusetts, United States

Research Site, Okemos, Michigan, United States

Research Site, St. Paul, Minnesota, United States

Research Site, St. Louis, Missouri, United States

Research Site, Princeton, New Jersey, United States

Research Site, Kenilworth, New Jersey, United States

Research Site, Toms River, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

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

Research Site, CHAPEL HILL, North Carolina, United States

Research Site, Cleveland, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, TOLEDO, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Eugene, Oregon, United States

Research Site, Salem, Oregon, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Columbia, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, NASHVILLE, Tennessee, United States

Research Site, Houston, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, SAN ANTONIO, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Richmond, Virginia, United States

Research Site, Kirkland, Washington, United States

Research Site, Spokane, Washington, United States

Research Site, Morgantown, West Virginia, United States

Starting date: April 2006
Ending date: October 2007
Last updated: November 27, 2007