NCT00451490撤回不适用
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- the Pittsburgh Sleep Quality Index
研究概览
简要总结
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will increase HRV at the end of the treatment.
详细描述
Phase advance of HRV will be anticipated in agomelatine group. It is anticipated that both agomelatine and floxentine will have equal efficacy in improvement of depressive symptoms and increasement of HRV at the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian patients
- •Male or female
- •18 to 65 years outpatients
- •DSM-IV-TR criteria for Major Depressive Disorder
排除标准
- •Patients with cardiac conditions and other physical conditions contraindicated for drug study
- •Shift worker
- •Patients known to be non-responders to fluoxetine treatment
- •Pregnancy, or breastfeeding
结局指标
主要结局
the Pittsburgh Sleep Quality Index
the Leeds Sleep Evaluation Questionnaire
次要结局
- heart rate variability
研究者
研究点 (2)
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