Efficacy and Safety Study of Seroquel SR in the Treatment of Generalized Anxiety Disorder
Phase 3
Completed
- Conditions
- Generalized Anxiety Disorder
- Registration Number
- NCT00322595
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).
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
- 800
Inclusion Criteria
- Male or female aged 18 to 65 years;
- A diagnosis of generalized anxiety disorder;
- Absence of current episode of major depression.
Exclusion Criteria
- The presence or history of schizophrenia and other psychotic disorders;
- Hypertension;
- A current diagnosis of cancer, unless in remission for at least 5 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD) at Day 57 (= end of treatment).
- Secondary Outcome Measures
Name Time Method To evaluate efficacy by evaluating response rate.
Trial Locations
- Locations (1)
Research Site
🇸🇪Uppsala, Sweden