To compare the efficacy and tolerability of methylphenidate and atomoxetine in children with attention deficit hyperactivity disorder.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, Mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score, Mean Adverse Effect Checklist Score.
研究概览
简要总结
This study is a prospective, randomized, open label trial comparing efficacy and tolerability of Methylphenidate (upto 1mg/kg/day) and Atomoxetine (upto 1.2mg/kg/day) for 8 weeks in 60 patients with attention deficit hyperactivity disorder which is being conducted in Government Medical College and Hospital, Chandigarh. The primary outcome measures are mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, mean Adverse Effects Checklist Score assessed weekly for 8 weeks and mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score assessed at baseline and 8 weeks. The secondary outcome measures are mean Social Adjustment Inventory for Children and Adolescent score and mean Clinical Global Impression Severity Score at 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients from 6 to 15 years of age with the diagnosis of Attention Deficit Hyperactivity Disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision.
- •Patients with moderate to severe illness as assessed by Clinical Global Impressions Severity Scale.
- •Patients whose parents are willing to provide informed consent for participating in the study.
排除标准
- •Patients with history of non-response or adverse drug reactions to methylphenidate or atomoxetine in the past.
- •Patients who have taken any medication for ADHD in past one month.
- •Patients with history of heart disease, seizures, bipolar affective disorder, psychotic illness, pervasive developmental disorder, substance abuse, anxiety, mental retardation or tic disorder.
结局指标
主要结局
Mean Vanderbilt ADHD Diagnostic Parent Rating Scale Score, Mean Vanderbilt ADHD Diagnostic Teacher Rating Scale Score, Mean Adverse Effect Checklist Score.
时间窗: Weekly assessments on Vanderbilt ADHD Diagnostic Parent Rating Scale and Adverse Effect Checklist for 8 weeks. Vanderbilt ADHD Diagnostic Teacher Rating Scale Assessment at baseline and 8 weeks.
次要结局
- Mean Clinical Global Impression Severity Scale Score(8 weeks)
- Mean Social Adjustment Inventory for Children and Adolescent Score(8 weeks)