TREATMENT OF ADHD IN CHILDREN WITH TOURETTES SYNDROME

抽动秽语综合征儿童多动症的治疗

基本信息

批准号：
6349557
负责人：
ROGER M KURLAN
金额：
$ 9.68万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
1996
资助国家：
美国
起止时间：
1996-07-01 至 2002-06-30
项目状态：
已结题

项目摘要

The pharmacologic treatment of children suffering from the particular combination of attention deficit hyperactivity disorder (ADHD) and chronic tics has been problematic. Although stimulants can be very effective for ADHD, such drugs are known to accentuate tics in some patients. Recent studies indicate that methylphenidate (MPH) may be the stimulant least likely to exacerbate tics and that such effects may be minor or temporary. Many open-label reports indicate that clonidine is beneficial, but recent controlled clinical trials have produced conflicting results. No study has examined the combined effects of MPH and clonidine. We propose a randomized, double-blind, parallel groups clinical trial which employs a 2 x 2 factorial design, whereby children with ADHD and chronic tics are assigned to one of 4 treatments: 1) MPH, 2) clonidine, 3) MPH plus clonidine, and 4) placebo. The study will involve 136 subjects enrolled among 7 centers. Each subject will participate in the trial for 16 weeks. A teacher-derived measure of ADHD will serve as the primary endpoint variable. Secondary measures of ADHD will include a parent-derived rating, another teacher rating, a computerized performance task and independent ratings of observed classroom behavior. Secondary analyses will also assess effects on tic severity and ratings of clinical improvement and global functioning. Since recent evidence indicates that ADHD and tics commonly coexist, the determination of the optimal treatment for this patient population is particularly important.

患有特定儿童的药理治疗注意力缺陷多动症（ADHD）和慢性抽动是有问题的。虽然兴奋剂可能非常有效多动症，已知这种药物会在某些患者中加剧抽搐。最近的研究表明哌醋甲酯（MPH）可能是刺激性最小的可能加剧抽搐，并且这种影响可能是次要的或暂时的。许多开放标签的报告表明可乐定是有益的，但最近对照临床试验产生了矛盾的结果。没有研究已经检查了MPH和可乐定的综合作用。我们提出了一个随机，双盲，平行组临床试验采用2 x 2阶乘设计，该设计有多动症和多动症儿童慢性抽搐分配给四种治疗方法之一：1）MPH，2）可乐定，， 3）MPH加上可乐定和4）安慰剂。该研究将涉及136 受试者在7个中心中注册。每个主题将参加试验16周。教师衍生的多动症措施将作为主要端点变量。多动症的次要措施将包括父母衍生的评级，另一个教师评级，计算机化的表现观察到的课堂行为的任务和独立评分。次要分析还将评估对抽动严重程度和临床评级的影响改进和全球功能。由于最近的证据表明ADHD和TICS通常是共存的确定该患者人群的最佳治疗是特别重要。