Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
试验速览
- 阶段
- 4 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- ADHD symptoms improvement
研究概览
简要总结
The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment.
In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants
- •Also they suffer from sleep onset insomnia or difficult awakening
排除标准
- •Drug treatment for ADHD or for sleep problems in the last 6 months
- •Any other chronic medical treatment
- •Sleep disorder requiring a different treatment
- •Asthma in the last 2 years
研究组 & 干预措施
Melatonin treatment
Treatment with Melatonin before sleep for 1 month - 3 mg for body weight <40kg, 6mg for body weight >40kg
干预措施: Melatonin (Drug)
Stimulants treatment
Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.
干预措施: Methylphenidate (Drug)
结局指标
主要结局
ADHD symptoms improvement
时间窗: a month
ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report
次要结局
- Sleep difficulties improvement(1 month)