CONTROLLED STUDY OF METHYLPHENIDATE IN ADULTS WITH ADHD

描述（申请人摘要）：这是R29的重新提交 这是一个经过广泛修订的提案。 尽管日益 注意力缺陷多动障碍儿童 （多动症）通常长大后成为同样的障碍，很少有人知道 关于成人这种疾病的治疗。 有五个没有答复 关于ADHD成人MPH治疗的问题：1）什么是 稳健MPH疗法的功效（即，剂量高达1.0 mg/kg/天） 使用DSM-IV诊断的成人，联合类型标准？，2)是什么 ADHD成人对MPH？的中期反应，3)什么是安全和 MPH治疗的中期耐受性4）MPH相关 6个月后，在没有MPH的情况下， 对ADHD成年人的有效治疗5）将MPH相关 ADHD治疗学的改善转化为功能的改善， 能力（神经心理，社会和职业）以及 6个月有效治疗后生活质量提高7 最后，申请人提出了一项双盲、安慰剂对照研究， 评估MPH的疗效和耐受性，每日剂量高达1.0 治疗DSM-IV诊断为ADHD的成人， 儿童期发病 仔细的诊断评估方法和临床 将使用有意义的剂量，对功能测量的影响将 接受检查。 具体的假设将在三个阶段中的每一个进行审查 双盲、安慰剂对照、平行研究设计。 一阶段 这项研究将包括为期六周的疗效评估。 在阶段 II期; I期缓解的受试者将每四周进行一次评估， 六个月 在第三阶段，一半的MPH受试者将接受 在四周内盲目停药， 他们的哌醋甲酯剂量 将维持双盲 在方案的每个阶段。 该研究将包括150名受试者 ADHD的诊断使用来自于 儿童情感障碍和精神分裂症量表 使用成人结构化临床访谈的共病疾病 紊乱 基于DSM-IV的诊断和症状特异性评定量表 也将被使用。 ADHD评定量表与临床总体印象量表 量表将用于评估ADHD的总体严重程度和改善情况 医学。 心理社会功能和生活质量也将 评估。 听觉和视觉连续执行任务以及 Stroop检验将用于进一步评估治疗疗效。 更大的 神经心理成套测验将用于评估 MPH治疗。

DESCRIPTION (Applicant's abstract): This is a resubmission of an R29 proposal that has been extensively revised. Despite the increasing recognition that children with attention deficit hyperactivity disorder (ADHD) commonly grow up to be adults with the same disorder, little is known about the treatment of this disorder in adults. There are five unanswered questions regarding the MPH treatment of ADHD adults: 1) what is the efficacy of robust MPH therapy (i.e., doses of up to 1.0 mg/kg/day) in ADHD adults diagnosed using DSM-IV, combined type criteria?, 2) what is the medium-term response of ADHD adults to MPH?, 3) what is the safety and tolerability of MPH treatment over the medium-term 4) can MPH-associated improvements in ADHD symptomatology be sustained without MPH after 6 months of effective treatment in ADHD adults ?, and 5) will MPH-associated improvements in ADHD symptomatology translate into improved functional capacities (neuropsychological, social and occupational) as well as increased quality of life after 6 months of effective treatment 7 To this end, the applicant proposes a double-blind, placebo- controlled, study to evaluate the efficacy and tolerability of MPH using daily doses of up to 1.0 mg/kg/day in the treatment of adults with the DSM-IV diagnosis of ADHD of childhood-onset. Careful diagnostic-assessment methods and clinically meaningful doses will be used and the effects on measures of function will be examined. Specific hypotheses will be examined in each of three phases of a double-blind, placebo-controlled, parallel study design. Phase I of the study will consist of a six week assessment of efficacy. During Phase II; subjects who respond in Phase I will be assessed every four weeks for six months. In Phase III, half of the MPH subjects will have their medication discontinued blindly over a four week period and half will remain on their dose of methylphenidate. The double-blind will be maintained throughout each Phase of the protocol. The study will include 150 subjects with the diagnosis of ADHD assessed using the module on ADHD derived from the Kiddie- Schedule for Affective Disorders and Schizophrenia and that of comorbid disorders using the Structured Clinical Interview for adult disorders. Diagnostic and symptom specific rating scales based on DSM-IV will also be used. The ADHD Rating Scale and the Clinical Global Impression Scale will be used to assess global severity and improvement of ADHD symptomatology. Psychosocial functioning and Quality of Life also will be assessed. The auditory and visual continuous performance tasks and the Stroop test will be used to further assess treatment efficacy. A larger neuropsychological battery will be used to assess the long term effects of MPH treatment.