NCT00300378已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
Wyeth is now a wholly owned subsidiary of Pfizer43 个研究点 分布在 10 个国家目标入组 480 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 43
- 主要终点
- The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
研究概览
简要总结
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary diagnosis of MDD
- •Depressive symptoms for at least 30 days before the screening visit.
排除标准
- •Treatment with DVS SR at any time in the past.
- •Known hypersensitivity to venlafaxine
- •Significant risk of suicide based on clinical judgment
结局指标
主要结局
The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
次要结局
- The Global Clinical Improvement will be the key secondary efficacy variable.
研究者
研究点 (43)
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