Prospective Follow-Up Observational Study to Examine the Progression of ADHD Drug Treatment and to Analyze Associated Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 主要终点
- Change from baseline in the ADHD Rating Scale (ARS)
研究概览
简要总结
The purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time version (K-SADS-PL).
详细描述
This is a 1-year open-label (all people involved know the identity of the assigned drug), multicenter, single arm, prospective, observational study to explore under natural setting the efficacy of drug treatment in children and adolescents diagnosed with ADHD by K-SADS-PL (K-SADS-PL is a tool used for ADHD diagnosis. Patient may be diagnosed with ADHD by using K-SADS-PL to check if he or she meets the criteria according to Diagnostic and Statistical Manual of Mental Disorders & edition (DSM-IV). After obtaining informed consent, investigator will prescribe stimulant or non-stimulant ADHD treatment medications (ie, Immediate release [IR]/extended release [ER]/osmotic release oral system (OROS) methylphenidate, atomoxetine). Efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the first day of giving study drug. Progression of symptom improvement and adherence will be investigated and associated variables (ie, demographic, clinical, familial and treatment factors) will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has been diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-SADS-present and life time version (K-SADS-PL)
- •Have not received methylphenidate or atomoxetine within 3 months prior to screening.
排除标准
- •Has intelligence quotient (IQ) ≤70 assessed by comprehensive attention test (CAT) at screening diagnosed with congenital disorders
- •Has had history of acquired brain damage (eg, cerebral palsy)
- •Has had diagnosed with convulsive disabilities or other neurological disease or dysesthesia
- •Has had developmental disabilities such as autistic spectrum disorder
- •Has had history of schizophrenia, bipolar, or other pediatric psychotic disorder, and obsessive compulsive disorder
- •Has had linguistic disability and had diagnosed with tic disorder that requires additional drug treatment.
研究组 & 干预措施
Patients with ADHD
Patients will receive methylphenidate hydrochloride or atomoxetine. The methylphenidate hydrochloride is available in three forms. 1) Immediate release 2) Extended release 3) Osmotic release oral system
干预措施: Methylphenidate hydrochloride (Drug)
Patients with ADHD
Patients will receive methylphenidate hydrochloride or atomoxetine. The methylphenidate hydrochloride is available in three forms. 1) Immediate release 2) Extended release 3) Osmotic release oral system
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Change from baseline in the ADHD Rating Scale (ARS)
时间窗: Baseline and Week 52
The ADHD Rating Scale (ARS) - Parent Version: ARS contains 18 items, in which parent version of the questionnaire is based on home behaviors.
次要结局
- Clinical Global Impression-Severity (CGI-S)(Baseline to Week 52)
- Adherence Rate(Week 4 to Week 52)
- Comprehensive Attention Test (CAT)(Baseline, Week 24 and Week 52)
- Academic Performance Rating Scale (APRS)(Baseline, Week 24 and Week 52)
- Symptoms Checklist (SCL-90) for Parent Depression(Baseline, Week 24 and Week 52)
- Clinical Global Impression- Improvement (CGI-I)(Baseline and Week 52)