NCT01040429已完成2 期
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean steps/day count during one week
研究概览
简要总结
The purpose of this study IS to
- explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions
- to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persisting or constantly relapsing fatigue lasting 3 months or more.
- •Functional disability resulting from fatigue to a degree that prevent normal school attendance
排除标准
- •Another disease process or current demanding life event that might explain the fatigue
- •Another chronic disease (in particular pheochromocytoma, polyneuropathy, Renal insufficiency)
- •Permanent use of pharmaceuticals (including hormone drugs)
- •Permanently bed-ridden
- •Positive pregnancy test
- •Evidence of reduced cerebral and/or peripheral circulation due to vessel disease
- •Know hypersensitivity towards clonidine or inert substances (lactose, sakkarose) in capsula
- •Abnormal ECG (in particular bradyarrythmias due to sick sinus syndrome or AV-block. Isolated ectopic beats do not lead to exclusion)
- •Supine heart rate < 50 beats/min
- •Supine systolic blood pressure < 85 mmHg
- •Systolic blood pressure fall upon standing > 30 mmHg
研究组 & 干预措施
Clonidine capsula
Active Comparator
干预措施: Clonidine (Drug)
Lactose capsula
Placebo Comparator
干预措施: Lactose capsula (Drug)
结局指标
主要结局
Mean steps/day count during one week
时间窗: 8 weeks after inclusion
次要结局
- Fatigue scores(8 and 30 weeks after inclusion)
- Pain scores(8 and 30 weeks after inclusion)
- Algometer testing response(8 and 30 weeks after inclusion)
- Autonomic symptom scores(8 and 30 weeks after inclusion)
- Quality of life-score(8 and 30 weeks after inclusion)
- Disability scores(8 and 30 weeks after inclusion)
- School attendance(8 and 30 weeks after inclusion)
- Mean steps/day count during one week(30 weeks after inclusion)
- Scores on cognitive function tests(8 and 30 weeks after inclusion)
- The change in mean arterial pressure (MAP) during head-up tilt-test(8 and 30 weeks after inclusion)
- The change in heart rate during head-up tilt-test(8 and 30 weeks after inclusion)
- The change in LF/HF-ratio (a measure of autonomic control) during head-up tilt-test(8 and 30 weeks after inclusion)
- Hormonal levels (inluding tryptophan metabolites)(8 and 30 weeks after inclusion)
- Microbiological analyses(8 and 30 weeks after inclusion)
研究者
Vegard Bruun Wyller
Associate professor
Oslo University Hospital
研究点 (1)
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