NCT00136383已完成2 期
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
Duke University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- R-R interval change with deep breathing
研究概览
简要总结
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.
详细描述
This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressive symptoms
- •Ages 20-60
- •In good medical health and not pregnant
排除标准
- •Bipolar disorder
- •Schizophrenia or other psychotic disorder
- •Alcohol or other substance abuse within the last 3 months
- •Cognitive impairment
- •History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS
结局指标
主要结局
R-R interval change with deep breathing
Respiratory sinus arrhythmia
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Connor-Davidson Resilience Scale
- Norepinephrine receptor occupancy
- Serotonin receptor occupancy
- Hospital Anxiety and Depression Scale
- Spielberger State-Trait Anxiety Inventory
研究者
研究点 (2)
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