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.
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