NCT00878748撤回4 期
An Open Label, Prospective and Multi-center Recurrence Prevention Study With Effexor XR in MDD Patients in China
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- time from entering maintenance phase to recurrence of major depression
研究概览
简要总结
This primary purpose of this study is to assess the efficacy and safety of Effexor XR in preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD) following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month continuation treatment phases. The study will also collect data on the prevalence and pattern of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.
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 —（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
研究组 & 干预措施
A
Experimental
Effexor XR
干预措施: Effexor XR (Drug)
B
Other
Effexor XR discontinue
干预措施: Effexor XR discontinue (Other)
结局指标
主要结局
time from entering maintenance phase to recurrence of major depression
时间窗: 12 months
次要结局
- Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36)(12 months)
研究者
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