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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 (GOLD)
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.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 800 |
| Start date | 2006-04 |
| Completion | 2007-09 |
Conditions
- Generalized Anxiety Disorder
Interventions
- Quetiapine Fumarate
- Escitalopram oxylate
Primary outcomes
- Change from randomization in the HAM-A total score at Day 57
Countries
United States