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临床试验/NCT01146002
NCT01146002已完成4 期

Language-based Learning Skills and ADHD: Impact of Treatment With Sustained-release Guanfacine

Neurology Group of Bergen County, P.A.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
one-tailed t-test

研究概览

简要总结

This study is investigating the effect of sustained-release guanfacine (Intuniv) on language-based learning skills in children age 6-12 who are diagnosed with attention deficit hyperactivity disorder (ADHD).

详细描述

LANGUAGE-BASED LEARNING SKILLS AND ADHD: IMPACT OF TREATMENT WITH SUSTAINED-RELEASE GUANFACINE

Background:

Children with attention-deficit/hyperactivity disorder (ADHD) often do poorly in school (1,2,3). Their slow academic progress is typically attributable to inattention, restlessness, disorganization and distractibility, all of which diminish their ability to learn. Additionally, these manifestations of ADHD may worsen an underlying specific learning disability (SLD), which is a common comorbidity of ADHD (1,4,5).

Treatment for ADHD is often initiated with the goal of enhancing learning and fostering academic success. Yet changes in academic achievement resulting from the pharmacological treatment of ADHD have been less evaluated in clinical research than changes in specifically defined behaviors. Such behaviors typically include lack of attention to task, fidgeting, calling out, disorganization and hyperactivity. These behaviors, rather than overall academic improvement, are also what are measured with typical ADHD rating scales (6).

A relatively small number of clinical studies have assessed the impact of medications for the treatment of ADHD on academic progress during childhood or adolescence. Some of these studies (3,7) have focused on long-term measures, such as lack of grade retention and ultimate graduation from high school. Other research has tried to directly measure the effect of medication for ADHD on the ability to perform particular academic tasks. Typically, the ability to efficiently and correctly solve a series of arithmetical problems - first, with no treatment, and then while taking stimulant medication, has been measured (8,9). These studies have demonstrated that both methylphenidate-based and amphetamine-based stimulant drugs enable greater speed, efficiency and accuracy.

研究设计

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

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ADHD-inattentive or combined type.

排除标准

  • Intelligence (IQ) below 85 as determined by formal testing.
  • Identified or suspected genetic syndromes.
  • Autism or other pervasive developmental disorders.
  • Psychiatric disorders other than ADHD and oppositional defiant disorder.
  • Heart, liver or renal disease.
  • Epilepsy or non-febrile seizure history.
  • Cardiac arrhythmia, bradycardia, or syncope.
  • Any other condition considered to be potentially exacerbated or endangered by treatment with an alpha-2 agonist drug.

研究组 & 干预措施

Guanfacine treated.

Other

Single arm - all patients treated with study drug. Comparison is against pre-treatment performance.

干预措施: Guanfacine (sustained release) (Drug)

结局指标

主要结局

one-tailed t-test

时间窗: 7 weeks

Improvement in Woodcock Johnson III score when taking sustained release guanfacine, compared to score on the same test prior to treatment.

次要结局

未报告次要终点

研究者

发起方
Neurology Group of Bergen County, P.A.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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