METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS

哌醋甲酯治疗 TS 儿童 ADHD

• 批准号: 6052795
• 负责人: KENNETH D GADOW
• 金额: $ 31.48万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-02-01 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6052795
• 关键词: Tourette'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)

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， 儿童抽动秽语综合征与慢性抽动障碍并存 患者不幸的是，最安全，有效，广泛使用的 用于ADHD的药物治疗，即哌甲酯，通常是 被认为会加剧抽搐，因此在这种情况下是禁忌的。 患者因为（a）哌甲酯的药理学替代品是 通常与药物不良反应的风险增加有关，或者 有效的ADHD行为，和（B）有很少的控制 对抽动障碍儿童长期使用兴奋剂的研究， 迫切需要检查 哌醋甲酯用于抽动障碍儿童的ADHD（ADHD/+抽动）， 制定临床应用的药物评价程序。主 本研究的目的是（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 抽搐、多动症和反社会行为的发展变化，以及情绪和 焦虑症状 这项拟议的研究是对82名患者进行长期随访研究的继续。 6至12岁的儿童谁有ADHD/+抽搐，谁会（或 参加（d）为期8周的安慰剂对照双盲 哌甲酯评价。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 教室和医生，教师和家长的评级量表。系统 每6个月进行一次症状状态评估， 2年，然后每隔12个月再延长3年（即，最小 5年）。评估抽动严重程度和共病内在化的影响 和外在症状的临床结果，儿童多动症/+抽搐将 与11岁时患有ADHD/抽搐的儿童的额外样本进行比较 和16年。