NCT00136383已完成2 期
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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)
Loading locations...
相似试验
已完成
3 期
Concomitant Use of PriLigy in Men Treated for Erectile DysfunctionErectile DysfunctionSexual DysfunctionNCT01063855Johnson & Johnson Pharmaceutical Research & Development, L.L.C.495
已完成
3 期
Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature EjaculationPremature EjaculationNCT01024491MorePharma Corporation174
已完成
2 期
Double Blind Trial of Duloxetine in Chronic Fatigue SyndromeFatigue Syndrome, ChronicNCT00375973University of Cincinnati60
已完成
3 期
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive DisorderDepressive DisorderNCT03315793Shionogi149
已完成
4 期
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular ComponentChronic Low Back PainNCT01166048Medical University of Vienna41