The Effect of a Once Daily Evening Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- mean sleep onset latency
研究概览
简要总结
Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly experience difficulty in initiating and maintaining sleep. Studies have shown that daytime sleepiness resulting from insufficient sleep can affect attention and learning. Therefore, treating insomnia in children with ADHD may not only improve sleep, but it could potentially improve ADHD symptoms as well.
The main purpose of this study is to examine the effects of atomoxetine on ADHD-related insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep in children with ADHD. During the study, participants will receive either atomoxetine or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep will differ from those of placebo, with atomoxetine having a greater effect on improving sleep difficulties.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boy or girl aged 6-17 years, inclusive, and English-speaking
- •Meet the DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder
- •Have sleep initiation defined by:
- •difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver
- •sleep onset delay that is not exclusively related to direct or rebound effects of psychostimulant treatment
- •Have a parent or legal guardian willing to participate in the study
排除标准
- •Have any other primary sleep disorder(s) (e.g. obstructive sleep apnea or periodic limb movement disorder)
- •Have a history of significant chronic medical (e.g. diabetes, severe asthma) or psychiatric (e.g. depression) illness
- •Have a history of chronic use of sedating (e.g. antihistamines) or alertness enhancing (e.g. caffeine) medications
- •Have a history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial with atomoxetine
结局指标
主要结局
mean sleep onset latency
parent and child-reported evening settling difficulties
次要结局
- ADHD symptom improvement
- night wakings, sleep duration, and sleep efficiency
- daytime sleepiness
- executive functions and functional outcomes/quality of life