NCT01997580Unknown4 期
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
研究概览
简要总结
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder
详细描述
Case-control study Repeated measures design
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV-TR major depressive disorder
- •aged between 20 and 80
- •durg-naive or drug-free
排除标准
- •DSM-IV-TR substance-related disorders (except nicotine)
- •significant medical or neurological conditions
- •mental retardation or organic brain damage
研究组 & 干预措施
Escitalopram
Experimental
depressed patients receiving escitalopram treatment
干预措施: escitalopram (Drug)
结局指标
主要结局
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
时间窗: 0, 3, 7, 14, and 42 days
the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state
次要结局
- Change in cardiorespiratory coupling during 6 weeks(0, 3, 7, 14, and 42 days)
- Change in persistent homology during 6 weeks(0, 3, 7, 14, and 42 days)
- Change in HF during 6 weeks(0, 3, 7, 14, and 42 days)
研究者
Jae Seung Chang
Associate Professor
Seoul National University Bundang Hospital
研究点 (1)
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