Comprehensive Pathophysiological Study Based on the Core Neurocognitive Deficits and Development of Biological Markers of Treatment Response in Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Treatment response measured by changes in CPT score
研究概览
简要总结
The purpose of this study was to identify genetic, brain morphologic, and environmental biomarkers that contribute to the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).
详细描述
The investigators planned to recruit ADHD and healthy controls from the age of 6 to 17.
Genetic data including dopamine, norepinephrine, serotonin, neurotropic factors, glutamate-related genes will be genotyped.
Environmental disruptors including phthalate and cotinine will be analyzed. Brain MRI data including T1, diffusion tensor imaging (DTI), resting state functional MRI (rsfMRI) will be obtained.
Neuropsychological tests including continuous performance test, Stroop test, Children's color trail test, Wisconsin card sorting test will be conducted.
The investigators plan to identify biomarkers of ADHD using an integrative approach of genetic, environmental, neuroimaging and clinical data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of attention-deficit/hyperactivity disorder confirmed using the Kiddie-Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version- Korean Version (K-SADS-PL-K).
- •IQ over 70
排除标准
- •Intelligence quotient (IQ) < 70
- •A hereditary genetic disorder
- •A current/past history of brain trauma, organic brain disorder, seizure, or any neurological disorder
- •Autism spectrum disorder, communication disorder, or learning disorder
- •Schizophrenia or any other childhood-onset psychotic disorder
- •Major depressive disorder or bipolar disorder
- •Tourette's syndrome or chronic motor/vocal tic disorder
- •obsessive-compulsive disorder
- •A history of methylphenidate treatment lasting more than 1 year or received within the previous 4 weeks
研究组 & 干预措施
Methylphenidate
ADHD patients with methylphenidate administration Generic names include concerta, metadata and penid. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.
干预措施: methylphenidate (Drug)
Atomoxetine
ADHD patients with atomoxetine administration Generic names include strattera. The initial dosage was fixed for 2 weeks and then adjusted according to the clinician's judgement. The patients visited the hospital at week 2,4,6,8,16,24, 9months, 12,15,18,21,24 months.
干预措施: atomoxetine (Drug)
结局指标
主要结局
Treatment response measured by changes in CPT score
时间窗: 6 months
The continuous performance test (CPT) is an objective measurement of ADHD symptom severity. It is a computerized test and the results are presented in 4 variables : omission errors, commission errors, response time, response time variability.
Treatment response measured by decrease in ADHD-RS scale
时间窗: 6 months
Changes in the Parent rated ADHD-Rating Scale - IV (ADHD-RS), which is an 18 item scale, with 9 items assessing inattention and 9 items assessing hyperactivity/impulsivity. It is the most widely used scale to measure symptom severity of attention-deficit/hyperactivity disorder.
Treatment response measured by CGI-I score
时间窗: 6 months
The Clinical Global Impression - Improvement (CGI-I) scale is a clinician rated scale used to measure improvement in symptoms. It ranges from 1 to 7, with 1 meaning very much improved, and 7 meaning very much worse.
次要结局
- Treatment response measured by CGI-I score(1 year)
- Side effects measured using the side effect rating scale (SRS)(1 year)
- Treatment response measured by decrease in ADHD-RS scale(1 year)
研究者
Booog Nyung Kim
Professor
Seoul National University Childrens Hospital