CAREER DEVELOPMENT AWARD IN PEDIATRIC PSYCHOPHARMACOLOGY

拟议的新少数民族教师指导科学家发展奖（K01-MSDA-NMF）概述了儿童精神药理学临床，以患者为中心的研究的职业发展计划，特别关注广泛性发育障碍（pdd）。在过去的两年里，在精神病学少数民族研究培训项目（PMRTP）的资助下，我在这一临床研究领域取得了丰硕的成果。我曾参与耶鲁大学成功申请儿科精神药理学研究单位（RUPP）合同，重点关注pdd，参与设计和实施多地点协作工作，进行小规模临床试验，并完成精神药理学和其他发育障碍（如Prader-Willi综合征）的自然研究。拟议的K01将为我提供一个获得必要的额外技能和培训的机会，成为一名儿科精神药理学的独立研究员。为了实现我科学独立的长期目标，我们设计了一个全面的培训计划来补充我提出的研究活动。在医学博士James F. Leckman的主要指导下，我开发了一套正式教学、研讨会、教程和校外实地考察的课程，重点关注以下关键领域：1)药效学和药代动力学原理；2) PDD的分类学和评估；3)临床试验方法学；4)科学伦理行为；5)统计和定量技能；6)卫生服务的基本方面和有效性研究；7)组织、管理和拨款写作技能。两项建立在该领域初步临床试验基础上的研究被提出作为所描述的培训计划的背景和实际基础：1)一项双盲、安慰剂对照的低剂量氟伏沙明治疗被诊断为阿斯伯格综合症的青少年的强迫、强迫和一般焦虑症状的研究；2)在美国食品和药物管理局（FDA）批准的新药研究（IND）下，ziprasidone进行了一项试点、开放标签研究，用于治疗与自闭症相关的攻击性、冲动和自残行为。

The proposed Mentored Scientist Development Award for New Minority Faculty (K01-MSDA-NMF) outlines a program of career development in clinical, patient-centered research in pediatric psychopharmacology, and specifically focused on the pervasive developmental disorders (PDDs). Over the past two years, and while supported by a grant from the Program for Minority Research Training in Psychiatry (PMRTP), I have been productively engaged in this area of clinical research. I have participated in Yale s successful application for a Research Unit in Pediatric Psychopharmacology (RUPP) contract focused on the PDDs, been involved in the design and implementation of multi-site collaborative efforts, conducted smaller scale clinical trials, and completed naturalistic studies in psychopharmacology and in other developmental disabilities, such as Prader-Willi syndrome. The proposed K01 would provide me with an opportunity to acquire the necessary additional skills and training to become an independent researcher in pediatric psychopharmacology. To achieve my long-term goal of scientific independence, a comprehensive training plan has been designed to complement my proposed research activities. Under the primary mentorship of James F. Leckman, M.D., I have developed a curriculum of formal didactics, seminars, tutorials and extramural site visits that will focus on the key areas of: 1) Pharmacodynamic and pharmacokinetic principles; 2) PDD nosology and assessment; 3) Clinical trial methodology; 4) Ethical conduct of science; 5) Statistics and quantitative skills; 6) Basic aspects of health services and effectiveness research; and 7) Organizational, administrative, and grant-writing skills. Two studies that build on preliminary clinical trials in the field are proposed as the context and the practical substrate for the training plan described: 1) A double-blind, placebo- controlled study of low-dose fluvoxamine in the treatment of obsessive, compulsive, and general anxiety symptoms in adolescents diagnosed with Asperger s syndrome; and 2) A pilot, open-label study of ziprasidone, conducted under Investigational New Drug (IND) approval from the Food and Drug Administration (FDA), in the treatment of aggressive, impulsive and self- injurious behaviors associated with autistic disorder.