CAREER DEVELOPMENT AWARD IN PEDIATRIC PSYCHOPHARMACOLOGY

拟议的新少数族裔教师导师科学家发展奖 (K01-MSDA-NMF) 概述了儿科精神药理学临床、以患者为中心的研究的职业发展计划，特别关注普遍性发育障碍 (PDD)。在过去的两年里，在少数民族精神病学研究培训计划 (PMRTP) 的资助下，我一直富有成效地从事这一领域的临床研究。我参与了耶鲁大学成功申请的儿科精神药理学研究单位 (RUPP) 合同，重点关注 PDD，参与了多中心协作工作的设计和实施，进行了较小规模的临床试验，并完成了精神药理学和其他发育障碍（如普瑞德威利综合征）的自然主义研究。 拟议的 K01 将为我提供获得必要的额外技能和培训的机会，以成为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，我们设计了一项全面的培训计划来补充我拟议的研究活动。 在 James F. Leckman 医学博士的主要指导下，我开发了一套正式教学、研讨会、辅导和校外实地考察课程，重点关注以下关键领域：1) 药效学和药代动力学原理； 2）PDD疾病分类学和评估； 3) 临床试验方法学； 4）科学道德行为； 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。两项基于该领域初步临床试验的研究被提议作为所述培训计划的背景和实际基础：1）一项双盲、安慰剂对照研究，研究低剂量氟伏沙明治疗诊断为阿斯伯格综合症的青少年的强迫性、强迫性和一般性焦虑症状； 2) 齐拉西酮的一项试点、开放标签研究，在美国食品和药物管理局 (FDA) 的研究性新药 (IND) 批准下进行，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.