Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 30
- 主要终点
- Evolution of the ADHD rating scale IV inattention subscore
研究概览
简要总结
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences.
In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 6 to 15 years and 11 months;
- •male or female;
- •with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
- •children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.
排除标准
- •Patients below 6 years old or patients older than 16 years;
- •with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
- •mental retardation defined by a score < 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
- •established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).
结局指标
主要结局
Evolution of the ADHD rating scale IV inattention subscore
时间窗: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks
Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.
次要结局
- Evolution of the ADHD rating scale IV global score(Change from baseline in ADHD rating scale IV global score at 12 to16 weeks)
- Evolution of the ADHD rating scale IV hyperactivity subscore(Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks)