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Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)

2011年4月19日 更新者:Peking University

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

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.

研究概览

地位

未知

研究类型

介入性

注册 (预期的)

100

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing
      • Beijing、Beijing、中国、100191
        • 招聘中
        • Peking University Sixth Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 16年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:atomoxetine
Atomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d, then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks. If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d and maintained for 4 weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
大体时间:an expected average of 8 weeks
Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
an expected average of 8 weeks

次要结果测量

结果测量
措施说明
大体时间
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
大体时间:an expected average of 8 weeks
Change from baseline in ADHD Rating Scale: IV (Parent Rated) after optimal dose treated for 4 weeks
an expected average of 8 weeks
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
大体时间:An expected average of 8 weeks
Change from baseline in ADHD Rating Scale: IV (Teacher Rated) after optimal dose treated for 4 weeks
An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
大体时间:An expected average of 8 weeks
Change from baseline in IOWA Conners Rating Scale (Parent Rated) after optimal dose treated for 4 weeks
An expected average of 8 weeks
Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
大体时间:An expected average of 8 weeks
Change from baseline in IOWA Conners Rating Scale (Teacher Rated) after optimal dose treated for 4 weeks
An expected average of 8 weeks
Improvement in Clinical Global Impression: Severity
大体时间:An expected average of 8 weeks
Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
An expected average of 8 weeks
Side effect
大体时间:An expected average of 8 weeks
Number of Subjects with Side effects
An expected average of 8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (预期的)

2011年12月1日

研究注册日期

首次提交

2011年4月14日

首先提交符合 QC 标准的

2011年4月19日

首次发布 (估计)

2011年4月20日

研究记录更新

最后更新发布 (估计)

2011年4月20日

上次提交的符合 QC 标准的更新

2011年4月19日

最后验证

2011年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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