NCT02333149撤回3 期
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean change in sleep onset latency (minutes)
研究概览
简要总结
This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial insomnia in children with attention-deficit disorder.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •School-aged children and adolescents between the ages of 6 to 17 years
- •Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
排除标准
- •Co-morbid psychiatric/neurological diagnoses that may affect sleep
- •Co-morbid seizure disorder
- •Co-morbid sleep disorder
- •Concurrent use of immunosuppressive drugs, blood pressure drugs, selective serotonin re-uptake inhibitors or anticoagulant drugs;
- •Pregnancy or breastfeeding
研究组 & 干预措施
Placebo
Placebo Comparator
Drug: Placebo
干预措施: Placebo (Drug)
Melatonin
Experimental
Dietary supplement: Melatonin 3 mg or 6 mg
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Mean change in sleep onset latency (minutes)
时间窗: Daily, up to 6 weeks
The mean change in sleep onset latency will be measured using sleep diaries.
次要结局
未报告次要终点
研究者
研究点 (1)
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