NCT00191659已完成3 期
A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
研究概览
简要总结
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.
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
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHD
排除标准
- •Patients who weigh less than 20kg at visit 1
- •Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures
- •Judged to be at suicidal risk
- •Taking psychotropic medication on a regular basis
- •Hypertension
结局指标
主要结局
To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
次要结局
- CHIP-CE total mean score after 4 weeks of treatment.
- The domains of the CHIP-CE after 4 and 10 weeks of treatment.
- The following are measured after both 4 and 10 weeks of treatment:
- Family Buden of Illness
- Harter Self Perception Profile
- ADHD-RS
- Clinical Global Impression- Severity
- Clinical Global Impression -Improvement
- To assess whether changes to the above scales are maintained over long term
- Long-term safety of atomoxetine
研究者
研究点 (2)
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