NCT00191932已完成4 期
Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 14
- 主要终点
- To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
研究概览
简要总结
A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine
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
- •Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD)
- •Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment
- •Exclusion Criteria include:
- •Current primary Axis I disorder other than MDD
- •Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- •Patients judged to be at serious suicidal risk.
- •Serious medical illness
排除标准
- 未提供
结局指标
主要结局
To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
次要结局
- To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures.
研究者
研究点 (14)
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