A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period

AstraZeneca114 个研究点分布在 2 个国家目标入组 575 人开始时间: 2006年3月1日最近更新: 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: 575
试验地点: 114
主要终点: Time from randomisation to occurrence of an anxiety event

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 primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised 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.

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

•Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.

排除标准

•Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.

结局指标

主要结局

Time from randomisation to occurrence of an anxiety event

次要结局

In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (114)

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