Melatonin - Production and Release in Children and Adolescents With ADHD and Chronic Sleep Problems and Effects of Melatonin on Sleep
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sleep onset
研究概览
简要总结
Treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially.
In a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release.
There seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents.
As can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD
- •Verified Cronical Sleep Problems
- •Measured Dim Light Melatonin Onset
排除标准
- •IQ below 70
- •Autism Disorder
- •Actual or former treated with Melatonin
- •Allergy to melatonin
研究组 & 干预措施
Sleep problems i Attention Deficit Hyperactivity Disorder
Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)
干预措施: Melatonin 3 mg (Drug)
结局指标
主要结局
Sleep onset
时间窗: 6 month
Time where child falls asleep
Sleep onset Latency (SOL)
时间窗: 6 month
How long time does the child use falling asleep after lights out
Total Sleep time
时间窗: 6 month
次要结局
- Dundee Difficult Times of the Day Scale (D-DTODS)(6 month)
- Weiss Functional Impairment Rating Scale (WFIRS)(6 month)
- Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)(6 month)
- Side effect Rating Scale(6 month)
研究者
Allan Hvolby
Principal Investigator, MD, Ph.D
Region of Southern Denmark