NCT01204086Unknown4 期
Pharmacogenomics Studies of Antidepressants
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.
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
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 16-65 years old
- •Signed informed consent by patient or legal representative
- •Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
- •A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry
排除标准
- •monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
- •A DSM-IV diagnosis of substance abuse within the past three months
- •An organic mental disease, mental retardation or dementia
- •A serious surgical condition or physical illness
- •Patients who were pregnant or breastfeeding
研究组 & 干预措施
venlafaxine
Experimental
干预措施: Venlafaxine (Drug)
fluoxetine
Experimental
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: 6 weeks
次要结局
- C-reactive Protein and IL-6(6 weeks)
- fasting blood glucose, lipid profiles(6 weeks)
研究者
研究点 (1)
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