NCT02127736已完成不适用
Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin
Winfried Rief1 个研究点 分布在 1 个国家开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Percentage of rapid eye movement (REM) sleep
研究概览
简要总结
The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 years to 69 years
- •willingness to refrain from alcohol consumption throughout the study
- •regular sleeping habits
- •fluent in German language
- •is not dependent on driving to get to the study center
- •provide written informed consent
- •ability to understand the explanations and instructions given by the study physician and the investigator
排除标准
- •Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history
- •allergies to amitriptyline hydrochloride or any of its ingredients
- •acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
- •urinary retention
- •untreated closed-angle glaucoma
- •prostatic hyperplasia
- •pyloric stenosis
- •paralytic ileus
- •suicidal thoughts
- •liver/ kidney/ pulmonary insufficiency
- •myasthenia gravis
- •hypokalemia
- •bradycardia
- •coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
- •increased risk of seizures/ history of seizures
- •substance dependence syndrome/ history of substance dependence syndrome
- •Allergies to ingredients of placebo or novel-tasting drink (CS)
- •currently pregnant (verified by urine pregnancy test) or lactating
- •patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)
- •patients suffering from a medical condition (assessed by the study physician)
- •Concomitant medication interfering with study medication intake due to potential interactions
- •participation in any other clinical trial 3 months prior to visit 1
- •employee of the Sponsor or the principal investigator
研究组 & 干预措施
Experimental group
Experimental
干预措施: Amitriptyline (Drug)
Experimental group
Experimental
干预措施: Placebo (Drug)
Control group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of rapid eye movement (REM) sleep
时间窗: 5 nights during the study
assessed by polysomnography
Objective Total Sleep Time
时间窗: 5 nights during the study
assessed by polysomnography
次要结局
未报告次要终点
研究者
Winfried Rief
Prof. Dr. Winfried Rief
Philipps University Marburg Medical Center
研究点 (1)
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