ARIPIPRAZOLE IN CHILDREN AND ADOLESCENTS WITH AUTISTIC DISORDER

阿立哌唑用于患有自闭症的儿童和青少年

• 批准号: 7717499
• 负责人: Christopher J McDougle
• 金额: $ 0.13万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717499
• 关键词: Adolescent; Adult; Adverse effects; Agonist; Antipsychotic Agents; Autistic Disorder; Behavior; Child; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Disease; Dopamine; Dopamine D2 Receptor; Effectiveness; Enrollment; Funding; Grant; Individual; Institution; Label; Maintenance; Monitor; Outcome Measure; Pharmacotherapy; Population; Rate; Research; Research Personnel; Resources; Safety; Serotonin; Source; System; Titrations; United States National Institutes of Health; Week; abnormal involuntary movement; aripiprazole; atypical antipsychotic; day; dopamine system; dosage; impression; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label study of the effectiveness, tolerability, and safety of aripiprazole for the treatment of interfering behaviors commonly observed in children and adolescents with autistic disorder. Research suggests that a dysregulation of dopamine and serotonin systems contributes to interfering behaviors in autistic individuals. Because of the increased propensity for adverse effects with typical neuroleptics and the atypical antipsychotics (albeit significantly less), there remains a need for a safe and effective pharmacotherapy for youngsters in this population. Aripiprazole, a partial agonist at the dopamine D2 receptor, may be considered a dopamine system stabilizer. Preliminary research demonstrating efficacy in adult subjects, and more recent research of aripiprazole in youngsters with conduct disorder, found no serious adverse effects. This evidence suggests that aripiprazole may be an ideal compound, regarding effectiveness and tolerability, for autistic individuals. The 14-week study will enroll 20 children and adolescents with autism where subjects will receive 5 mg/day of aripiprazole, with the opportunity to increase to a maximum dosage of 15 mg over a 4-week period, as tolerated. After titration, subjects will continue on aripiprazole for an 8-week maintenance period. Response will be determined by ratings of primary outcome measures: the Clinical Global Impression Scale (CGI)-Improvement scale and the irritability subscale of the Aberrant Behavior Checklist (ABC). Adverse effects will be monitored with the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Rating Scale, and the Side Effects Review Form. Data will be analyzed with the intent to gain a preliminary understanding of the effectiveness, tolerability, and safety of aripiprazole in children and adolescents with autism. This exploratory study will serve to stimulate more definitive, controlled research.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项开放标签研究，旨在探讨阿立哌唑治疗自闭症儿童和青少年中常见的干扰行为的有效性、耐受性和安全性。 研究表明，多巴胺和血清素系统的失调会导致自闭症患者的行为受到干扰。 由于典型抗精神病药和非典型抗精神病药的不良反应倾向增加（尽管明显较少），因此仍然需要针对该人群的年轻人安全有效的药物治疗。 阿立哌唑是多巴胺 D2 受体的部分激动剂，可被视为多巴胺系统稳定剂。 初步研究证明阿立哌唑对成人受试者有效，最近的研究也发现阿立哌唑对行为障碍青少年没有严重的副作用。 这一证据表明，就有效性和耐受性而言，阿立哌唑对于自闭症患者可能是一种理想的化合物。 这项为期 14 周的研究将招募 20 名患有自闭症的儿童和青少年，受试者将每天接受 5 毫克阿立哌唑，并有机会在 4 周内根据耐受情况增加至最大剂量 15 毫克。 滴定后，受试者将继续服用阿立哌唑 8 周维持期。 反应将根据主要结果指标的评级来确定：临床总体印象量表（CGI）-改善量表和异常行为检查表（ABC）的烦躁子量表。 将使用异常不自主运动量表 (AIMS)、辛普森-安格斯评定量表和副作用审查表来监测不良反应。 将分析数据，旨在初步了解阿立哌唑对自闭症儿童和青少年的有效性、耐受性和安全性。 这项探索性研究将有助于激发更明确、受控的研究。