METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS

描述(改编自申请人的摘要)：研究清楚地表明 注意缺陷多动障碍(ADHD)是一种常见的行为 儿童抽动症合并慢性抽动障碍 病人。不幸的是，最安全、最有效、最广泛使用的 ADHD的药物治疗，即哌甲酸甲酯，通常是 被认为加剧抽搐，因此在这样的情况下被禁忌 病人。因为(A)哌醋甲酯的药理替代品是 通常与药物不良反应的风险增加或较少相关 对ADHD行为有效，以及(B)很少受到控制 抽动障碍儿童长期使用兴奋剂的研究， 迫切需要检查该药的安全性和有效性。 哌醋甲酯治疗抽动障碍(ADHD/+抽动)儿童的ADHD 制定临床应用的药物评价程序。初级阶段 拟议研究的目标是：(1)评估短期和长期影响 对患有ADHD/TICS+的儿童进行刺激药物治疗，以及(2)描述 抽动、多动症和反社会行为的发育变化，以及情绪和 焦虑症状。 这项拟议的研究是对82项长期跟踪研究的继续 患有ADHD/+抽搐的6至12岁儿童，以及将(或 参加(D)为期8周的双盲安慰剂对照试验 哌甲酸甲酯评估。ADHD和抽动障碍的药物反应 在模拟诊所中使用直接观察法评估症状。 教室以及医生、教师和家长评分表。系统化 症状状态评估每隔6个月进行一次，至少 2年，然后每隔12个月再延长3年(即最低 5年)。评估抽动的严重程度和合并内化的影响 和外化症状对临床结果的影响，患有ADHD/+抽搐的儿童将 与另外一组11岁患有ADHD/抽搐的儿童进行比较 以及16年。

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.