CAREER DEVELOPMENT AWARD IN PEDIATRIC PSYCHOPHARMACOLOGY

儿科精神药理学职业发展奖

• 批准号: 6477023
• 负责人: ANDRES S MARTIN
• 金额: $ 14.39万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6477023
• 关键词: Asperger syndrome; adolescence (12-20); antidepressants; antipsychotic agents; anxiety disorders; autism; clinical research; human subject; human therapy evaluation; impulsive behavior; mental disorder chemotherapy; middle childhood (6-11); pediatric pharmacology; piperazines; psychopharmacology; serotonin inhibitor; tranquilizer

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.

拟议的新少数民族教师指导科学家发展奖（K 01-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，并特别关注广泛性发育障碍（PDDs）。在过去的两年里，在精神病学少数民族研究培训计划（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，重点是PDD，参与设计和实施多地点合作努力，进行小规模的临床试验，并完成了精神药理学和其他发育障碍的自然主义研究，如Prader-Willi综合征。 拟议的K 01将为我提供一个机会，获得必要的额外技能和培训，成为一个独立的研究人员在儿科精神药理学。为了实现我的科学独立的长期目标，设计了一个全面的培训计划，以补充我提出的研究活动。 在James F. Leckman，医学博士，我已经开发了一个正式的教学，研讨会，辅导和校外网站访问，将集中在以下关键领域的课程：1）药效学和药代动力学原理; 2）PDD疾病分类和评估; 3）临床试验方法; 4）科学道德行为; 5）统计和定量技能; 6）卫生服务和有效性研究的基本方面; 7）组织、行政和撰写赠款的技能。建立在该领域的初步临床试验基础上的两项研究被提出作为所描述的训练计划的背景和实践基础：1）低剂量氟伏沙明治疗被诊断为Alzheimer综合征的青少年的强迫症、强迫症和广泛性焦虑症状的双盲、安慰剂对照研究;和2）齐拉西酮在治疗与自闭症相关的攻击性、冲动性和自伤行为中的试验性、开放标签研究，在食品和药物管理局（FDA）的研究性新药（IND）批准下进行。