NOVEL PHARMACOLOGICAL STRATEGIES IN AUTISM

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。 尽管目前无法治愈自闭症，但适当使用药物和心理社会治疗可以减少许多相关的适应不良行为。 这种变化往往会增强个人从教育和职业机会中受益的能力，并在尽可能不受限制的情况下生活，从而提高个人及其家庭的生活质量。 本研究的目的是评估阿立哌唑对有明显易怒、攻击性和/或自残行为的自闭症儿童和青少年的安全性和有效性。 该研究还包括（对于符合资格的人）可选添加药物 D-环丝氨酸，以评估其治疗社会相关性的安全性和有效性。 本研究的目的是查明阿立哌唑是否有助于治疗烦躁、攻击性和/或自伤行为，以及确定添加 D-环丝氨酸是否可以改善自闭症儿童和青少年的社交行为。 这项研究将包括 88 名 6 至 17 岁的儿童和青少年。 这项研究分为几个阶段：第一阶段是双盲研究，持续约八周。在初始双盲阶段或随机接受安慰剂的 8 周开放标签试验中对阿立哌唑有反应的受试者将在 II 期中接受额外 16 周的治疗。 如果受试者继续反应良好，他/她将被允许在他/她正在进行的阿立哌唑治疗中添加 D-环丝氨酸额外 8 周。

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. Although there is currently no cure for autism, the appropriate use of medication and psychosocial treatment can reduce many of the associated maladaptive behaviors. Such change often enhances the person's ability to benefit from educational and vocational opportunities and to reside in the least restrictive alternative possible, thus resulting in an improved quality of life for the individual and his or her family. The goal of this study is to evaluate the safety and effectiveness of aripiprazole in children and adolescents with autism who have significant irritability, aggression and/or self injurious behavior. The study also includes an optional addition (for those who qualify) of the medication, D-cycloserine to evaluate its safety and effectiveness for the treatment of social relatedness. The purpose of this study is to find out if aripiprazole is helpful for the treatment of irritability, aggression and/or self-injurious behavior as well as to determine if adding D-cycloserine improves social behavior in children and adolescents with autism. This study will include 88 children and adolescents aged 6 - 17 years. There are several phases in this study: the first phase is a double-blind study lasting approximately eight weeks. Subjects responding to aripiprazole during either the initial double-blind phase or the 8 week open-label trial for those subjects randomized to placebo, will be offered an additional 16 weeks of treatment in Phase II. If the subject continues to respond well, he/she will be allowed to add D-cycloserine to his/her ongoing treatment of aripiprazole for an additional 8 weeks.