Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 主要终点
- The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
研究概览
简要总结
This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment
详细描述
This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6 to 12 years
- •Diagnosis of ADHD according to DSM-5 of ICD-10
- •Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
- •Patient who has a stable clinical symptoms.
- •Patients or their legal representatives provide informed consent prior to enrollment
排除标准
- •Patients who present of a serious obstructive gastrointestinal disease
- •Patients cannot swallow the whole tablet
- •Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
- •Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
- •Patients or patients' family have a history of poor compliance
- •Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days
- •Patients who receiving PR-MPH except stop taking more than 7 days
- •Patients' parent has a family problem and currently treatment with family therapy or adjust medication
研究组 & 干预措施
original
This study use 18 and 36 mg of original prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.
干预措施: prolong-release methylphenidate (Drug)
generic
This study use 18 and 36 mg of generic prolong-release methylphenidate. Dosing of Medication is equivalent to immediate-release. Medication administration is once daily in the morning.
干预措施: prolong-release methylphenidate (Drug)
结局指标
主要结局
The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
时间窗: baseline, 4 and 8 week
SNAP-IV,26 items score, included 18-items that reflect ADHD symptoms and 8-items that reflect oppositional defiant disorder symptoms
次要结局
- The change from baseline in Clinical Global Impression-Severity (CGI-S) scale(baseline, 4 and 8 week)
- The difference in discontinuation rate between two groups of treatment(4 and 8 week)
- The difference in adverse events rate between two groups of treatment(baseline, 4 and 8 week)