NCT00644982已完成4 期
A Multicenter Randomized, Double-Blind, Parallel-Group Study of Sertraline Versus Venlafaxine XR in the Acute Treatment of Outpatients With Major Depressive Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2002年10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
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
研究概览
简要总结
To assess the comparative efficacy of sertraline versus venlafaxine XR on measures of quality of life.
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 (Participant, Investigator)
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
- •Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent, without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only if they are identified as secondary diagnoses.
- •Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1 (depressed mood) score ≥2.
排除标准
- •Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- •Current or past diagnosis of bipolar disorder or any psychotic disorder.
研究组 & 干预措施
Sertaline group
Experimental
干预措施: sertraline (Drug)
Venlafaxine group
Active Comparator
干预措施: venlafaxine XR (Drug)
结局指标
主要结局
Change from baseline in QOL, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
时间窗: Weeks 1, 2, 3, 4, 6, 8, 9 and 10.
次要结局
- Change from baseline in the Hamilton Anxiety Scale (HAM-A).(Weeks 1, 2, 3, 4, 6, 8, 9 and 10.)
- Change from baseline in the CGI-Severity Scale (CGI-S).(Weeks 1, 2, 3, 4, 6, 8, 9 and 10.)
- Change from baseline in the 17-item Hamilton-Depression Rating Scale (HAM-D) including response (≥50% reduction in HAM-D total score from baseline) and remission (HAM-D total score ≤7) rates.(Weeks 1, 2, 3, 4, 6, 8, 9 and 10.)
- The 17-item Hamilton-Depression Rating Scale response rates at endpoint (week 8).(Week 8)
- CGI response rate at endpoint (week 8).(Week 8)
- Change from baseline in the Visual Analogue Scale (VAS) for Overall Assessment of Pain.(Weeks 1, 2, 3, 4, 6, 8, 9 and 10.)
- Hamilton-Depression Rating Scale remission rates at endpoint (week 8).(Week 8)
- Change from baseline in the Visual Analogue Scale (VAS) for Depression.(Weeks 1, 2, 3, 4, 6, 8, 9 and 10.)
- Change from baseline in the Clinical Global Impression-Improvement Scale.(Weeks 1, 2, 3, 4, 6, 8)
- Change from baseline in the Endicott Work Productivity Scale (EWPS).(Weeks 1, 8, 9, 10)
研究者
研究点 (1)
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