Pharmacological Treatment of ADHD in Young Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Change in ADHD-IV Rating Scale Total Score
研究概览
简要总结
This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.
详细描述
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent and child must be English speaking
- •Child has been living with parent/guardian for at least six months
- •Meets criteria for ADHD on the DISC, on clinical interview, and on clinical consensus conference
- •ADHD is primary disorder with symptoms present for at least 9 months
- •ADHD-IV-Rating Scale (ADHD-IV-RS)score that is at least 1.5 standard deviations above age and sex norms
- •Score of 55 or below on the Children's Global Assessment Scale
- •Score of 4 or greater on the Clinical Global Impression Scale
- •Estimated Intelligence Quotient (IQ) of 70 or greater
- •Currently participating in school at least 2 half-days per week
- •Able to identify a teacher who can make valid assessments
- •Patient and parent are able to attend regular study visits
排除标准
- •Currently taking other psychotropic medications or other medications with effects on the central nervous system
- •Currently being treated effectively with atomoxetine
- •Major medical conditions that might interfere with study medications
- •History of or current clinically significant kidney illness
- •Evidence of adjustment disorder, autism, psychosis, bipolar disorder, suicide ideations, or any other psychiatric disorder requiring treatment with additional psychotropic medication
- •History of physical, sexual, or emotional abuse impacting clinical presentation
- •Prior failure to respond to an adequate trial of atomoxetine
研究组 & 干预措施
atomoxetine and parent training
atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
干预措施: Atomoxetine (Drug)
atomoxetine and parent training
atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
干预措施: Parent Training (Behavioral)
placebo and parent training
matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
干预措施: Placebo (Drug)
placebo and parent training
matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks
干预措施: Parent Training (Behavioral)
结局指标
主要结局
Change in ADHD-IV Rating Scale Total Score
时间窗: Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.
Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology. The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27.
次要结局
- Change in Total ADHD-IV Teacher(Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.)