Pharmacological Treatment of ADHD in Young Children

幼儿多动症的药物治疗

• 批准号: 6613690
• 负责人: CHRISTOPHER J KRATOCHVIL
• 金额: $ 15.1万
• 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/6613690
• 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）：这是一项以患者为导向的研究职业发展奖（K23）的申请，旨在为 Christopher Kratochvil 博士提供必要的培训和指导，使他成为一名早期儿童精神药理学的独立临床研究员， NIMH 确定的培训新调查员具有最高优先级的领域。杜克大学医学中心精神病学教授 John March 医学博士、公共卫生硕士和内布拉斯加大学医学中心精神病学教授 William J. Burke 医学博士将担任该奖项的联合主要导师。职业发展计划包括教学、儿科临床研究指导和两阶段临床试验。教学议程与研究计划紧密结合，提供了研究设计、生物统计学、流行病学、药代动力学、儿童发育和生物医学研究伦理学方面的系统学习课程。课程将通过内布拉斯加大学医学中心的理学硕士课程进行。学前精神药理学、研究设计、人类受试者研究伦理、生物统计学、发育行为儿科和学龄前儿童诊断评估等方面的地方和国家专家将提供指导。临床研究经验包括对患有多动症的幼儿进行阿托莫西汀（一种选择性去甲肾上腺素能再摄取抑制剂）的两阶段评估。第一阶段是一项开放标签可行性试验，评估 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，评估同一人群的安全性、耐受性和有效性。这些试验将是一次体验式教育机会，同时为未来的独立研究提供试点数据，并将为未来的独立研究奠定基础。奖励期第 4 年学前精神药理学的 R01 提交。完成该奖项后，候选人将在幼儿精神药理学领域建立外部资助的独立研究生涯，其次关注与儿童临床研究有关的伦理问题。