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

AstraZeneca58 个研究点分布在 1 个国家目标入组 876 人开始时间: 2006年4月最近更新: 2009年3月25日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AstraZeneca
入组人数: 876
试验地点: 58
主要终点: Change from randomization in the HAM-A total score at Day 57

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•Patients (female) must not be pregnant or lactating
•Current or past diagnosis of stroke or transient ischemic attack (TIA).

结局指标

主要结局

Change from randomization in the HAM-A total score at Day 57

次要结局

Change from randomization in CGI-S score at Day 57

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (58)

Loading locations...

相似试验

已完成

3 期

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

NCT00329446AstraZeneca800

已完成

3 期

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive DisorderMajor Depressive Disorder

NCT00320268AstraZeneca600

已完成

3 期

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive DisorderMajor Depressive Disorder

NCT00321490AstraZeneca600

已完成

3 期

Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive DisorderMajor Depressive Disorder

NCT00388973AstraZeneca338

已完成

3 期

Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety DisorderAnxiety Disorders

NCT00389064AstraZeneca450