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METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS

哌醋甲酯治疗 TS 儿童 ADHD

基本信息

批准号：
6688983
负责人：
KENNETH D GADOW
金额：
$ 35.84万
依托单位：
STATE UNIVERSITY NEW YORK STONY BROOK
依托单位国家：
美国
项目类别：
财政年份：
1991
资助国家：
美国
起止时间：
1991-02-01 至 2005-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6688983
关键词：
Tourette&apos s syndrome attention deficit disorder clinical research clinical trials drug adverse effect drug screening /evaluation human subject human therapy evaluation mental disorder chemotherapy methylphenidate middle childhood (6-11)

项目摘要

DESCRIPTION (Adapted from the Applicant's Abstract): Research clearly indicates that attention-deficit hyperactivity disorder (ADHD) is a common behavioral concomitant of Tourette's syndrome (TS) and chronic tic disorder in child patients. Unfortunately, the most safe, effective, and widely used pharmacological treatment for ADHD, namely methylphenidate, has generally been thought to exacerbate tics and therefore to be contraindicated in such patients. Because (a) the pharmacological alternatives to methylphenidate are often associated with increased risk of adverse drug reactions or are less efficacious for ADHD behaviors, and (b) there is very little controlled research on the long-term use of stimulants in children with tic disorder, there is a compelling need to examine the safety and efficacy of methylphenidate for ADHD in children with tic disorder (ADHD/+tics) and to develop drug evaluation procedures for clinical application. The primary objectives of the proposed study are to (1) assess short- and long-term effects of stimulant drug therapy for children with ADHD/tics+, and (2) describe developmental changes in tics, ADHD and antisocial behaviors, and mood and anxiety symptoms. The proposed study is a continuation of a long-term follow-up study of 82 children between 6 and 12 years of age who have ADHD/+tics and who will (or have) participate (d) in an 8-week, placebo-controlled, double-blind methylphenidate evaluation. Drug response for both ADHD and tic disorder symptoms is assessed using direct observation procedures in a simulated clinic classroom and with physician, teacher, and parent rating scales. Systematic assessment of symptom status is conducted at 6-month intervals for a minimum of 2 years and then at 12-month intervals for an additional 3 years (i.e., minimum of 5 years). To evaluate the impact of tic severity and comorbid internalizing and externalizing symptoms on clinical outcome, children with ADHD/+tics will be compared with an additional sample of children with ADHD/-tics at ages 11 and 16 years.

描述（改编自申请人的摘要）：研究清楚地表明注意力缺陷多动障碍（ADHD）是一种常见的行为障碍儿童伴有抽动秽语综合征（TS）和慢性抽动障碍患者。不幸的是，最安全、有效和广泛使用的 ADHD 的药物治疗通常是哌醋甲酯被认为会加剧抽动，因此在此类情况下是禁忌的患者。因为 (a) 哌醋甲酯的药理学替代品是通常与药物不良反应风险增加相关或较少对 ADHD 行为有效，并且 (b) 几乎不受控制抽动障碍儿童长期使用兴奋剂的研究，迫切需要检查其安全性和有效性哌醋甲酯用于治疗抽动障碍 (ADHD/+抽动症) 儿童的 ADHD 制定临床应用的药物评价程序。初级拟议研究的目标是 (1) 评估短期和长期影响 ADHD/抽动症+儿童的兴奋剂药物治疗，以及 (2) 描述抽动症、多动症和反社会行为以及情绪和行为的发展变化焦虑症状。拟议的研究是对 82 项研究的长期跟踪研究的延续。 6 至 12 岁患有 ADHD/+ 抽动症并且将（或已经）参加（d）一项为期 8 周的安慰剂对照双盲试验哌醋甲酯评价。 ADHD 和抽动障碍的药物反应在模拟诊所中使用直接观察程序评估症状课堂上以及医生、教师和家长评分量表。系统化每 6 个月进行一次症状状态评估，评估时间至少为 2 年，然后每隔 12 个月再进行 3 年（即至少 5 年）。评估抽动严重程度和共病内化的影响并将症状外化到临床结果上，患有多动症/+抽动症的儿童将与另外一个 11 岁患有多动症/抽动症儿童样本进行比较和16年。