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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项开放标签的研究，对阿立哌唑对治疗自闭症儿童和青少年通常观察到的干扰行为的有效性，耐受性和安全性。 研究表明，多巴胺和5-羟色胺系统的失调有助于自闭症个体的干扰行为。 由于对典型的神经疗法和非典型抗精神病药的不良反应倾向增加（尽管较少），因此仍然需要对该人群中的年轻人进行安全有效的药物治疗。 Aripiprazole是多巴胺D2受体的部分激动剂，可能被认为是多巴胺系统稳定剂。 初步研究证明了成人受试者的功效，以及在行为障碍的年轻人中对阿立哌唑的最新研究，没有发现严重的不良反应。 该证据表明，对于自闭症患者，阿立哌唑可能是有效性和耐受性的理想化合物。 这项为期14周的研究将招募20名自闭症儿童和青少年，受试者将获得5 mg/天阿立哌唑，并有机会在4周的时间内增加到最高剂量为15 mg。 滴定后，受试者将继续在Aripiprazole进行为期8周的维护期。 响应将由主要结果度量的评分来确定：临床全球印象量表（CGI）改进量表和异常行为清单（ABC）的易怒子量表。 不良反应将通过异常的非自愿运动量表（AIMS），Simpson-Angus评级量表和副作用审查表格进行监测。 将分析数据，目的是对Aripiprazole对自闭症的儿童和青少年的有效性，耐受性和安全性进行初步了解。 这项探索性研究将有助于刺激更确定的对照研究。