A Twelve-Week, Open, Randomized Trial Comparing Valproate to Lithium in Bipolar I Patients Suffering From a Manic Episode

Sanofi0 个研究点目标入组 270 人开始时间: 2004年2月最近更新: 2007年11月16日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi
入组人数: 270
主要终点: Change from baseline to D END in the Young Mania Rating Scale total score

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Primary Objective :

To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a periode of 3 weeks and 12 weeks of treatment

Secondary Objective :

To evaluate the clinical and biological safety of valproate compared to lithium.

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: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

Change from baseline to D END in the Young Mania Rating Scale total score

次要结局

Change from baseline to each assessment in the YMRS score
Percentage of responders defined by a decrease of at least 50% in the YMRS score between D0 and D END
Percentage of responders at week 3 defined by a decrease of at least 50 % in the YMRS score between D0 and D21
Change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) (20) between D0 and D21
Change in the CGI-BP between D0 and D END
Change in the MADRS between D0 and D21 (MADRS: Montgomery and Asberg Depression Rating Scale )
Change in the MADRS between D0 and D END
Survival analyses: Time to achieve 50% and 30% improvement in the YMRS score; Time to antidepressant intake; Time to drop-out for any reason.

研究者

发起方

Sanofi

申办方类型

Industry

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