Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
研究概览
简要总结
The objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (ADHD). Participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for ADHD will be observed for 52 weeks. They will do several neuropsychological, neuroimaging and genetic tests at visit 1~6.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 6 and 12 years
- •met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy.
- •Informed consent
排除标准
- •presence of intellectual disability or learning disorder
- •past and/or current history of bipolar disorder or psychosis or substance use disorder
- •past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder
- •presence of sever suicidal ideation
- •presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy
- •presence of family history with Tourette's Syndrome
- •took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month)
- •presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma)
- •took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on Central Nervous System (CNS).
- •presence of possibility with pregnancy
- •especially for neuroimaging,
- •uncooperative with claustrophobia or body movement
- •metal material inside body that can't take off
研究组 & 干预措施
ADHD group
Children and adolescents who met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Subjects will be taking Methylphenidate or Atomoxetine for 52 weeks.
干预措施: Methylphenidate (MPH) (Drug)
ADHD group
Children and adolescents who met the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) diagnostic criteria for ADHD and needed pharmacotherapy. Subjects will be taking Methylphenidate or Atomoxetine for 52 weeks.
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Wide genome analysis regarding genetic polymorphisms as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
时间窗: visit 1 (-week 8)
Genome wide case-control association analysis will be operated with qualified phenotype and assigned intermittent phenotype.
Neuroimaging analysis as predictors of treatment response in Attention-Deficit/Hyperactivity Disorder(ADHD).
时间窗: visit 1 (-week 8)
Thickness of cortex, anatomical relation will be compared with 3 tesla MRI. In addition, brain circuit for delayed aversion, delayed frustration, time processing and resting state.
Drug effectiveness is assessed using ADHD rating scale, CGI -S (Clinical Global Impression - Severity scale) and CGI-I (Clinical Global Impression - Improvement scale).
时间窗: visit 1 (-week 8)
Neuropsychological markers as the treatment response predictable factor of ADHD using a complex neuropsychological test consisting of SSRT, delayed aversion, delayed frustration, time processing, ATA
时间窗: visit 1 (-week 8)
Using a complex neuropsychological test consisting of The stop-signal reaction time (SSRT) task, delayed aversion, delayed frustration, time processing, Advanced tets of Attention (ATA).
Comorbidity assessment using a composite measure consisting of K-PRC, C-SSRS, TCGI, and DCDQ
时间窗: visit1 (-week 8)
It is assessed using a composite measure consisting of Korean Personality Rating Scale for Children (K-PRC), Columbia Suicide Severity Rating Scale (C-SSRS), The Tic Severity Scale (TCGI), and The Developmental Coordination Disorder Questionnaire (DCDQ).
次要结局
未报告次要终点
研究者
Hyo-Won Kim
Assistant professor, department of psychiatry, Asan Medical Center
Asan Medical Center