Generalized Anxiety Disorder Clinical Trial
— TITANIUMOfficial 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
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
was changed to XR after consultation with FDA.
| Status | Completed |
| Enrollment | 876 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Charleston | West Virginia |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clementon | New Jersey |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Eagle | Idaho |
| United States | Research Site | Encino | California |
| United States | Research SIte | Fall River | Massachusetts |
| United States | Research Site | Farmington Hills | Michigan |
| United States | Research Site | Friendswood | Texas |
| United States | Research Site | Ft Walton Beach | Florida |
| United States | Research Site | Gainsville | Florida |
| United States | Research Site | Herndon | Virginia |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lincoln | Rhode Island |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Midlothian | Virginia |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York City | New York |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Norristown | Pennsylvania |
| United States | Research Site | Norwich | Connecticut |
| United States | Research Site | Oak Brook | Illinois |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Redlands | California |
| United States | Research Site | Ridgeland | Mississippi |
| United States | Research Site | Rochester | New York |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Smyrna | Georgia |
| United States | Research Site | Springdale | Arizona |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Staten Island | New York |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Winter Park | Florida |
| United States | Research Site | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from randomization in the HAM-A total score at Day 57 | |||
| Secondary | Change from randomization in CGI-S score at Day 57 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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