Pharmacological Treatment of ADHD in Young Children

幼儿多动症的药物治疗

• 批准号: 6876180
• 负责人: CHRISTOPHER J KRATOCHVIL
• 金额: $ 15.65万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6876180
• 关键词: adolescence (12-20); age difference; antidepressants; attention deficit disorder; clinical research; clinical trials; human data; human subject; human therapy evaluation; mental disorder chemotherapy; middle childhood (6-11); neurotransmitter antagonist; norepinephrine; patient oriented research; pediatric pharmacology; postdoctoral investigator; preschool child (1-5); psychopharmacology

DESCRIPTION (provided by candidate): This is a request for a Mentored Patient-Oriented Research Career Development Award (K23) to provide Dr. Christopher Kratochvil with the training and mentorship necessary to establish himself as an independent clinical researcher in early childhood psychopharmacology, an area identified by the NIMH as having the highest priority for training new investigators. John March, M.D., M.P.H., Professor of Psychiatry at Duke University Medical Center, and William J. Burke, M.D., Professor of Psychiatry at the University of Nebraska Medical Center, will serve as Co-Primary Mentors for the Award. The career development plan includes didactics, mentorship in pediatric clinical research, and a two-phase clinical trial. The didactic agenda, which is closely integrated with the research plan, provides a systematic course of study in research design, biostatistics, epidemiology, pharmacokinetics, child development, and the ethics of biomedical research. Coursework will be conducted through the Master of Science program at University of Nebraska Medical Center. Local and national experts in preschool psychopharmacology, research design, ethics in human subject research, biostatistics, developmental behavioral pediatrics, and diagnostic assessment of preschoolers will provide mentorship. The clinical research experience includes a two-stage assessment of atomoxetine, a selective noradrenergic reuptake inhibitor, in young children with ADHD. Stage I is an open-label feasibility trial assessing the study design and methodology in children ages 5-6. Stage II is a randomized, double-blind, placebo-controlled trial evaluating safety, tolerability, and efficacy in this same population, These trials will be an experiential educational opportunity, while providing pilot data for future independent research, and will set the stage for an R01 submission in preschool psychopharmacology in year 4 of the Award period. Upon completion of this Award, the candidate will have established an externally funded independent research career in early childhood psychopharmacology, with a secondary focus on ethical issues pertaining to clinical research with children.

描述（由候选人提供）：这是向受过指导的面向患者的研究职业发展奖（K23）的请求，旨在为克里斯托弗·克拉托奇维尔博士提供所需的培训和指导，以确立自己为幼儿心理药理学的独立临床研究人员，这是一种NIMH确定的区域是培训新调查人员的最高优先事项。杜克大学医学中心精神病学教授的John March，M.P.H.和内布拉斯加州大学医学中心精神病学教授William J. Burke，将担任该奖项的共同主要导师。职业发展计划包括教学，小儿临床研究的指导和两阶段临床试验。与研究计划密切相结合的教学议程提供了研究设计，生物统计学，流行病学，药代动力学，儿童发展和生物医学研究伦理方面的系统研究过程。课程将通过内布拉斯加州大学医学中心的科学硕士课程进行。学龄前心理药理学，研究设计，人类学科研究，生物统计学，发育行为的儿科和诊断学龄前儿童评估的地方和国家专家将提供指导。临床研究经验包括对ADHD的幼儿对原子氨酸的两阶段评估（一种选择性去甲肾上腺素能再摄取抑制剂）的评估。第一阶段是一项开放标签的可行性试验，评估了5-6岁儿童的研究设计和方法。第二阶段是一项随机，双盲，安慰剂对照试验，评估了同一人群的安全性，耐受性和效力，这些试验将是一个体验性的教育机会，同时为未来的独立研究提供了试验数据，并将为未来的独立研究提供阶段，并为奖项期4年的幼儿园心理药理学中的R01提交。该奖项完成后，候选人将在幼儿心理学上建立一项由外部资助的独立研究职业，第二个关注与儿童临床研究有关的道德问题。