CONTROLLED STUDY OF METHYLPHENIDATE IN ADULTS WITH ADHD

描述(申请人摘要)：这是R29的重新提交 已经被广泛修订的提案。尽管不断增加的 认识到注意缺陷多动障碍儿童 (ADHD)通常长大后会患上同样的疾病，目前知之甚少 关于成人这种疾病的治疗。有五个问题没有回答 关于成人ADHD的MPH治疗的问题：1)什么是 强健的MPH疗法(即每天剂量高达1.0 mg/kg)对ADHD的疗效 使用DSM-IV诊断的成年人，综合分型标准？2)什么是 ADHD成人对MPH的中期反应？，3)什么是安全性和 中期内公共卫生治疗的耐受性可能与公共卫生有关 ADHD症状的改善在6个月后在没有MPH的情况下持续 对成人多动症的有效治疗？以及5)公共卫生是否与 ADHD症状的改善转化为功能的改善 能力(神经心理、社会和职业)以及 经过6个月的有效治疗后生活质量提高7到 最后，申请人提出了一项双盲、安慰剂对照的研究，以 评估每日剂量不超过1.0的MPH的有效性和耐受性 Mg/kg/d治疗成人DSM-IV诊断的ADHD 童年--发病。仔细的诊断-评估方法和临床 有意义的剂量将被使用，对功能测量的影响将 接受检查。具体的假设将分三个阶段逐一进行检验。 一项双盲、安慰剂对照、平行研究设计。第I阶段： 这项研究将包括为期六周的疗效评估。在阶段中 II；在第一阶段有反应的受试者将每四周接受一次评估 六个月。在第三阶段，一半的公共卫生科目将有他们的 在四周内盲目停止用药，一半的人将继续服药 关于他们服用的哌甲酸甲酯。将保持双盲 在协议的每个阶段。这项研究将包括150名受试者 使用ADHD模块评估ADHD的诊断，该模块源自 儿童情感障碍和精神分裂症量表及其对儿童的影响 成人共病的结构化临床访谈研究 精神错乱。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 将使用该量表评估全球ADHD的严重程度和改善情况 症状学。心理社会功能和生活质量也将 评估过了。听觉和视觉连续表演任务和 将使用Stroop试验进一步评估治疗效果。一个更大的 将使用神经心理学组件来评估 公共卫生小时治疗。

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.