NOVEL PHARMACOLOGICAL STRATEGIES IN AUTISM

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。虽然目前还没有治愈自闭症的方法，但适当使用药物和心理治疗可以减少许多相关的适应不良行为。这种改变往往提高了个人从教育和职业机会中获益的能力，并使其居住在尽可能少限制的地方，从而提高了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。该研究还包括一个可选的附加（对于那些符合条件的人）药物，d -环丝氨酸，以评估其治疗社会关系的安全性和有效性。本研究的目的是发现阿立哌唑是否有助于治疗易怒、攻击和/或自残行为，以及确定添加d -环丝氨酸是否能改善自闭症儿童和青少年的社交行为。本研究将包括88名6 - 17岁的儿童和青少年。这项研究有几个阶段：第一阶段是一个持续大约8周的双盲研究。在初始双盲期或8周开放标签试验（随机分配到安慰剂组）中对阿立哌唑有反应的受试者，将在II期再接受16周的治疗。如果受试者仍然反应良好，他/她将被允许在他/她正在进行的阿立哌唑治疗中再添加d -环丝氨酸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.