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

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Quetiapine fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Willie Earley, 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 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, Placebo 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, Springdale, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Santa Ana, California, United States

Research Site, Newport Beach, California, United States

Research Site, Oceanside, California, United States

Research Site, Redlands, California, United States

Research Site, Encino, 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, Gainsville, Florida, United States

Research Site, Hialeah, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, Ft Walton Beach, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Smyrna, Georgia, United States

Research Site, Atlanta, Georgia, United States

Research Site, Eagle, Idaho, United States

Research Site, Chicago, Illinois, United States

Research Site, Oak Brook, Illinois, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Topeka, Kansas, United States

Research Site, New Orleans, Louisiana, United States

Research SIte, Fall River, Massachusetts, United States

Research Site, Farmington Hills, Michigan, United States

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

Research Site, Staten Island, New York, United States

Research Site, Brooklyn, New York, United States

Research Site, Rochester, New York, United States

Research Site, Durham, North Carolina, United States

Research Site, Charlotte, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Toledo, Ohio, United States

Research Site, Tulsa, Oklahoma, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Norristown, Pennsylvania, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Lincoln, Rhode Island, 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, Friendswood, Texas, United States

Research Site, Woodstock, Vermont, United States

Research Site, Herndon, Virginia, United States

Research Site, Midlothian, Virginia, United States

Research Site, Bellevue, Washington, United States

Research Site, Seattle, Washington, United States

Research Site, Charleston, West Virginia, United States

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