A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

AstraZeneca54 个研究点分布在 1 个国家目标入组 400 人开始时间: 2006年12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: 400
试验地点: 54
主要终点: Change from baseline in depression symptoms by final visit as measured by the MADRS total score

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 determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

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

•Provision of written informed consent
•Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
•Outpatient status at enrollment

排除标准

•Patients with >8 mood episodes during the past 12 years
•Use of prohibited medications
•Substance or alcohol abuse or dependence
•Current suicide risk or suicide attempt within last 6 months.

结局指标

主要结局

Change from baseline in depression symptoms by final visit as measured by the MADRS total score

次要结局

Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (54)

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