METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS

哌醋甲酯治疗 TS 儿童 ADHD

• 批准号: 2674950
• 负责人: KENNETH D GADOW
• 金额: $ 20.25万
• 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 1999-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2674950
• 关键词: Tourette's syndrome; attention deficit disorder; clinical trials; drug adverse effect; human subject; human therapy evaluation; mental disorder chemotherapy; methylphenidate; middle childhood (6-11)

Research conducted in our clinic and investigations in other university centers clearly indicate that Attention-Deficit Hyperactivity Disorder (ADHD) is a common behavioral concomitant of Tourette syndrome (TS) in child patients. For many individuals, ADHD symptoms are a greater impediment to social and academic success than their tics, particularly during the elementary school years. Unfortunately, the most safe, effective, and widely used pharmacological treatment for ADHD, namely methylphenidate, is widely thought to exacerbate TS symptoms and therefore to be contraindicated in such patients. Because (a) the pharmacological alternatives to methylphenidate are often associated with increased risk of adverse reactions (e.g., neuroleptics) or are less efficacious for extended use (e.g., imipramine) and (b) there is very little research on methylphenidate in TS patients, we believe that a compelling need exists to examine the safety and efficacy of methylphenidate for ADHD and TS symptoms and to develop drug evaluation procedures for clinical application. Further, such research may provide insight into the neurophysiology of TS. For the proposed study, 20 boys between 6 and 12 years of age and diagnosed as having both ADHD and TS will be entered into an eight-week placebo controlled, double-blind crossover study of methylphenidate. Drug conditions will consist of placebo and .1, .3, and .5 mg/kg of methylphenidate administered twice daily, each for two weeks. Medication will be dispenced in dated envelopes, and patients will be randomly assigned to counterbalanced dosage sequences. Drug responsivity of both ADHD and TS symptoms will be assessed using direct observation procedures in the school and in the clinic playroom, laboratory performance tests, and clinician, teacher, and parent rating scales. A placebo controlled, double-blind event-related potential (ERP) study will be conducted immediately following the medication evaluation to examine drug related changes in brain function. Ongoing ERP studies in our laboratory will permit comparisons between the study sample and normal and ADHD children. The final phase of the proposed study is a six-month followup during which time ADHD and TS symptoms will be routinely assessed to determine changes over time.

在我们诊所进行的研究和在其他大学的调查 研究中心明确指出，注意力缺陷多动障碍 多动症(ADHD)是抽动秽语综合征(TS)的一种常见行为伴随 儿童病人。对于许多人来说，ADHD的症状更严重 社会和学术成就的障碍比他们的抽搐更大，特别是 在小学的时候。不幸的是，最安全的 对ADHD进行有效且广泛使用的药物治疗，即 哌醋甲酯，被广泛认为会加剧TS症状，因此 是此类患者的禁忌症。因为(A)药理学 替代哌醋酸甲酯的药物通常会增加罹患 不良反应(如抗精神病药)或延长有效时间 使用(例如丙咪嗪)和(B)很少有关于 在TS患者中，我们认为迫切需要 观察哌醋甲酯治疗ADHD和TS症状的安全性和有效性 并制定临床应用的药物评价程序。 此外，这样的研究可能为TS的神经生理学提供洞察力。 在拟议的研究中，20名6至12岁的男孩被诊断为 同时患有ADHD和TS的患者将接受为期8周的安慰剂治疗 哌醋甲酯对照双盲交叉研究。药效 条件将包括安慰剂和.1、.3和.5毫克/公斤 哌醋甲酯每天服用两次，每次两周。用药 将被分发在注明日期的信封中，病人将被随机 分配到平衡剂量序列。两者的药物反应性 ADHD和TS症状将使用直接观察法进行评估 在学校和诊所的游戏室，实验室的表现测试，以及 临床医生、教师和家长评定量表。一种安慰剂对照， 将进行双盲事件相关电位(ERP)研究 在药物评估后立即检查与药物有关的 大脑功能的变化。我们实验室正在进行的ERP研究将 允许将研究样本与正常儿童和ADHD儿童进行比较。 拟议研究的最后阶段是六个月的后续行动，在此期间 将定期评估ADHD和TS症状以确定变化情况 随着时间的推移。