NCT00191633已完成4 期
A 3 Month Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder; Symptomatic and Functional Outcomes.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- To assess the correlation of change in score on an ADHD rating scale with the change in score on a functional rating questionnaire at 3 months post atomoxetine initiation
研究概览
简要总结
The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age
- •Patients must have moderately severe symptoms of ADHD.
- •Patients must be able to swallow study drug capsules.
排除标准
- •Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
- •Patients must not have taken atomoxetine prior to starting the study.
结局指标
主要结局
To assess the correlation of change in score on an ADHD rating scale with the change in score on a functional rating questionnaire at 3 months post atomoxetine initiation
次要结局
- Understand the relationships between ADHD symptoms, functional outcomes, and quality of life
- Explore the impact of data collection time points on efficacy, quality of life, and functional outcome
- Assess the efficacy of atomoxetine
- Use data collected to validate the WFIRS-P questionnaire
研究者
研究点 (19)
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