Pharmacotherapy of Pervasive Developmental Disorders

广泛性发育障碍的药物治疗

• 批准号: 7529306
• 负责人: Kimberly Stigler
• 金额: $ 18.42万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-24 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7529306
• 关键词: Acute; Adolescent; Adverse effects; Age; Aggressive behavior; Area; Asperger Syndrome; Autistic Disorder; Awareness; Behavior; Biometry; Caring; Child; Clinical Research; Data; Depth; Development; Diagnostic; Disease; Doctor of Medicine; Double-Blind Method; Effectiveness; Electrocardiogram; Impairment; Incidence; Indiana; International; Label; Maintenance; Master of Science; Mentored Clinical Oncology Award; Mentored Clinical Scientist Award; Mentored Patient-Oriented Research Career Development Award; Mentors; Not Otherwise Specified; Pervasive Development Disorder; Pharmaceutical Preparations; Pharmacotherapy; Phase; Phase I Clinical Trials; Placebo Control; Placebos; Prevalence; Principal Investigator; Prolactin; Psychopharmacology; Public Health; Publishing; Randomized; Research; Research Ethics; Research Methodology; Research Personnel; Safety; Self-Injurious Behavior; Surveys; Symptoms; Testing; Therapeutic; Universities; Week; Work; Youth; aripiprazole; career; cost; double-blind placebo controlled trial; improved; novel; placebo controlled study; programs; response; social skills

DESCRIPTION (provided by applicant): This K23 Award focuses on the psychopharmacology of pervasive developmental disorders (PDDs). Despite numerous treatment studies in autistic disorder (autism), research specifically focused on the diagnostic subtype of FDD not otherwise specified (NOS) is greatly lacking. In fact, there have been no published double-blind, placebo-controlled trials of any drug specific to this disorder. Moreover, recent epidemiological research has found that PDD NOS is the most common subtype of PDD. Therefore, it is critically important that pharmacologic research on PDDs other than autism be conducted. Often considered "higher functioning", these children suffer from severe lifelong impairments in core social skills and frequently associated irritability. Symptoms of irritability, including aggression, tantrums, and self- injury, can be more serious than those seen in autism. The candidate's long-term objective is to determine the most effective and safe pharmacologic treatments for PDDs, specifically PDD NOS. Her aims for this K23 Award are: (1) to develop an in depth understanding of clinical research and psychopharmacology by conducting a treatment study in PDD NOS; and (2) to obtain a Master of Science in Clinical Research degree at Indiana University, focusing on courses including research ethics, biostatistics, and research methodology. She will work closely with her mentor, Christopher J. McDougle, M.D., an international expert in the pharmacotherapy of PDDs, to accomplish these aims and transition into her career as an independent investigator. This proposal is a double-blind, placebo-controlled and open-label continuation study of aripiprazole for irritability in 60 children and adolescents with PDD NOS. Pilot data from the applicant suggests that aripiprazole is effective for targeting symptoms of irritability commonly observed in PDD NOS, including aggression, tantrums, and self-injury. Relevance: PDD NOS is a highly prevalent disorder often associated with severe irritability that impedes participation in educational, therapeutic, and vocational programs, with escalating costs of care. Thus, the development of safe and effective pharmacotherapies that improve irritability is clearly relevant to public health.

描述（由申请人提供）：该K23奖的重点是普遍发育障碍（PDDS）的心理药理学。尽管在自闭症（自闭症）方面进行了大量治疗研究，但主要缺乏未指定的FDD诊断子类型（NOS）的研究。实际上，没有针对该疾病的任何药物的双盲，安慰剂对照试验。此外，最近的流行病学研究发现，PDD NOS是PDD最常见的亚型。因此，至关重要的是，对自闭症以外的其他PDD进行药理学研究。这些孩子通常被认为是“更高的功能”，遭受了核心社交技能的严重终身障碍，并且经常会引起烦恼。烦躁的症状，包括攻击性，发脾气和自我伤害，比自闭症中看到的症状更严重。候选人的长期目标是确定PDD的最有效，最安全的药理治疗方法，特别是PDD NOS。她获得该K23奖的目标是：（1）通过在PDD NOS进行治疗研究来深入了解临床研究和心理药理学； （2）获得印第安纳大学临床研究学位的科学硕士学位，重点关注包括研究伦理，生物统计学和研究方法的课程。她将与她的导师Christopher J. McDougle，医学博士克里斯托弗·J·麦克杜格（Christopher J.该提议是一项双盲，安慰剂对照和开放标签的连续研究，对60名PDD NOS的60名儿童和青少年的烦躁不安。来自申请人的试点数据表明，阿立哌唑有效地靶向PDD NOS中通常观察到的易怒症状，包括攻击性，发脾气和自我伤害。相关性：PDD NOS是一种高度普遍的疾病，通常与严重的烦恼有关，阻碍了参与教育，治疗和职业计划，并且升级了护理费用。因此，改善烦躁的安全有效的药物治疗的开发显然与公共卫生有关。