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临床试验/NCT01204086
NCT01204086Unknown4 期

Pharmacogenomics Studies of Antidepressants

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年3月最近更新:
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

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

申办方类型
Other

研究点 (1)

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