A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
研究概览
简要总结
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atomoxetine
atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks
干预措施: Atomoxetine (Drug)
Placebo
placebo every day (QD), by mouth (PO) for 8 weeks
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
时间窗: Baseline and 8 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
次要结局
- ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score(28 weeks)
- Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)(8 weeks, 28 weeks)
- Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)(Baseline, 8 weeks, 28 weeks)
- Sleep Measure Scale(Baseline, 8 weeks, 28 weeks)
- Aberrant Behavior Checklist (ABC)(Baseline, 8 weeks, 28 weeks)
- Children's Social Behavior Questionnaire (CSBQ) Total Score(Baseline, 8 weeks, 28 weeks)
- General Health Questionnaire (GHQ) Total Score(Baseline, 8 weeks, 28 weeks)
- Nijmeegse Ouderlijke Stress Index (NOSI) Total Score(Baseline, 8 weeks, 28 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections(Baseline, 8 Weeks)
- Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates(Baseline, 8 weeks)
- Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times(Baseline, 8 weeks)
- Cytochrome P450 2D6 Genotype(baseline)