NOVEL PHARMACOLOGICAL STRATEGIES IN AUTISM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 虽然目前还没有治愈自闭症的方法，但适当地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获益的能力，并尽可能地在限制最少的替代方案中生活，从而改善个人及其家庭的生活质量。本研究的目的是评估阿立哌唑治疗自闭症儿童和青少年的安全性和有效性，这些儿童和青少年有明显的易怒、攻击和/或自残行为。这项研究还包括一种可选的药物添加剂D-环丝氨酸，以评估其治疗社交关系的安全性和有效性。本研究的目的是找出阿立哌唑是否有助于治疗易怒、攻击性和/或自残行为，以及确定添加D-环丝氨酸是否改善自闭症儿童和青少年的社会行为。这项研究将包括88名6-17岁的儿童和青少年。这项研究分为几个阶段：第一阶段是一项持续约8周的双盲研究。在最初的双盲期或随机服用安慰剂的8周开放试验中，对阿立哌唑有反应的受试者将在第二阶段再接受16周的治疗。如果受试者继续反应良好，他/她将被允许在正在进行的阿立哌唑治疗中再加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.