Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder
Phase 3
Completed
- Conditions
- Generalized Anxiety Disorder
- Registration Number
- NCT00329264
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 876
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
Read More
Exclusion Criteria
- Patients (female) must not be pregnant or lactating
- Current or past diagnosis of stroke or transient ischemic attack (TIA).
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from randomization in the HAM-A total score at Day 57
- Secondary Outcome Measures
Name Time Method Change from randomization in CGI-S score at Day 57
Trial Locations
- Locations (2)
Research SIte
🇺🇸Fall River, Massachusetts, United States
Research Site
🇺🇸Charleston, West Virginia, United States