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临床试验/NCT01339286
NCT01339286Unknown4 期

Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment

Peking University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)

研究概览

简要总结

Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Stimulants used to be the first line drug. But the medication compliance is poor because of strict drug administration. Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance. Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected. The rapid genotyping of large sample depends on high-through laboratory. New statistic method is to be used to improve the sensitivity of the target gene detection. There has been no such report in country and overseas. This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
  • The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
  • Han Chinese
  • Parent sign the informed consent

排除标准

  • Who are allergy to atomoxetine
  • Who can not complete the titration procedure because of untolerable of the side effect
  • Who combined other psychotropic drugs or non-drug intervention for ADHD.
  • Children who can not be compliant with the blood withdraw.

研究组 & 干预措施

atomoxetine

Experimental

干预措施: atomoxetine (Drug)

结局指标

主要结局

Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)

时间窗: an expected average of 8 weeks

Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks

次要结局

  • Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)(an expected average of 8 weeks)
  • Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)(An expected average of 8 weeks)
  • Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)(An expected average of 8 weeks)
  • Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)(An expected average of 8 weeks)
  • Improvement in Clinical Global Impression: Severity(An expected average of 8 weeks)
  • Side effect(An expected average of 8 weeks)

研究者

发起方
Peking University
申办方类型
Other

研究点 (1)

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