MEASURING AND PREDICTING RESPONSE TO ATOMOXETINE AND METHYLYPHENIDATE

测量和预测对托莫西汀和哌醋甲酯的反应

• 批准号: 7953672
• 负责人: JEFFREY H NEWCORN
• 金额: $ 1.88万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953672
• 关键词: Adolescent; Attention deficit hyperactivity disorder; Characteristics; Child; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Crossover Design; Data; Disease; Dose; Double-Blind Method; Funding; Genotype; Grant; Impairment; Individual; Institution; Measures; Methylphenidate; Neurobiology; Outcome; Public Health; Randomized; Relative (related person); Reporting; Research; Research Personnel; Resources; Safety; Site; Source; Subgroup; Symptoms; Testing; United States National Institutes of Health; Work; Youth; alternative treatment; atomoxetine; effective therapy; psychostimulant; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most frequently occurring disorders of children and adolescents, and represents a significant public health problem. A plethora of scientific data documents the robust efficacy and safety of psychostimulants for the management of ADHD symptoms and associated impairments. However, there is also considerable variability in response, with many individuals reporting lower levels of tolerability and palatability. Moreover, only a subgroup of those receiving stimulant treatments achieves a response that approximates normal functioning. The recent approval of atomoxetine (ATX) offers a non-stimulant alternative for the treatment of ADHD. ATX is structurally unrelated to the stimulants and appears to work via a different mechanism. Thus, ATX may be an effective treatment for those who cannot tolerate stimulants, or who have an inadequate response, and responders to the two treatments may have different clinical and neurobiological characteristics. This two-site study will evaluate the relative efficacy, tolerability and palatability of Concerta methylphenidate (MPH) and ATX in the treatment of children and adolescents with ADHD, using a randomized, double blind, cross-over design. To date, no study has compared the leading stimulant and non-stimulant treatments in large numbers of youth, using the most effective doses for each treatment, and evaluating response to both treatments in the same individuals. We will test the hypothesis that MPH and ATX have similar overall efficacy in 320 children, with sufficient statistical power to detect even a small effect size difference between the treatments. We will examine "normalization" of response, as well as more traditional outcomes, because the former more closely reflects the desired endpoint of treatment. We will additionally evaluate the potential moderating effects of genotype.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 注意力缺陷/多动症（ADHD）是最常见的儿童和青少年疾病之一，代表了一个重大的公共卫生问题。大量的科学数据记录了心理刺激因子对ADHD症状和相关障碍的管理的强大效率和安全性。但是，响应也有很大的可变性，许多人报告的耐受性和可口性水平较低。此外，只有接受刺激治疗的人的一个亚组才能达到近似正常功能的反应。最近批准阿托米西汀（ATX）为治疗多动症提供了一种非刺激替代方案。 ATX在结构上与兴奋剂无关，并且似乎通过不同的机制起作用。因此，对于那些无法忍受兴奋剂或反应不足的人，ATX可能是一种有效的治疗方法，对两种治疗的反应者可能具有不同的临床和神经生物学特征。这项两次研究将使用随机的，双重盲，跨界设计的儿童和青少年评估协奏曲哌醋甲酯（MPH）和ATX在儿童和青少年治疗儿童和青少年中的相对功效，耐受性和可口性。迄今为止，尚无研究比较大量青少年的领先兴奋剂和非刺激治疗方法，使用每种治疗的最有效剂量，并评估同一患者对两种治疗方法的反应。我们将检验以下假设：MPH和ATX在320名儿童中具有相似的总体疗效，并且具有足够的统计能力可以检测到治疗之间的效果大小差异。我们将检查反应的“归一化”，以及更传统的结果，因为前者更紧密地反映了所需的治疗终点。我们还将评估基因型的潜在调节作用。