RISPERIDONE AND BEHAVIOR THERAPY IN CHILDREN AND ADOLESCENTS WITH PERVASIVE D

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，不一定是研究者的机构。 广泛性发育障碍（PDD）是一种严重的发育状况，影响学龄儿童中每1000人中有6人。我们提出了一项多中心研究，其中120名伴有发脾气，攻击和/或自伤的PDD儿童将被随机分配到利培酮单独（N=40）或利培酮加结构化的父母管理培训计划（PMT）（N=80），然后在治疗8周和24周后比较适应和行为结果。 在第8周时，所有受试者将由独立评价者（对治疗分配设盲）分类为应答者或非应答者。 被归类为无应答者的儿童将有机会接受称为阿立哌唑的替代药物治疗。接受阿立哌唑治疗的儿童将继续在最初分配的组（仅药物治疗或药物治疗加PMT）中治疗最多16周。在第24周（总共6个月的治疗）时，仅对药物（利培酮或阿立吡唑）或药物+PMT组合（估计样本量为60）显示阳性反应的儿童将在10周内逐渐减少药物。停药阶段的目标是比较复发率（即，再次发脾气、攻击和/或自伤）（仅药物治疗与药物治疗加PMT）。纳入PDD儿童和青少年的理由是基于观察到PDD可能是社交，情感和学术领域的严重残疾。因此，迫切需要安全有效的PDD新治疗方法。

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. Pervasive Developmental Disorders (PDD) are serious developmental conditions affecting 6 per 1000 in school-age children. We propose a multi-site study in which 120 children with PDD accompanied by tantrums, aggression, and/or self-injury will be randomly assigned to risperidone only (N=40) or risperidone plus a structured parent management training program (PMT) (N=80) and then compared on adaptive and behavioral outcomes after 8 and 24 weeks of treatment. At the 8-week mark all subjects will be classified as a responder or non-responder by an independent evaluator (blind to treatment assignment). Children who are classified as non-responders will be offered an opportunity to receive treatment with an alternative medication called aripirazole. Children who go on aripirazole will continue in their originally assigned groups (medication only or medication plus PMT) for up to 16 more weeks. At the 24-week mark (6 months of treatment total), children who demonstrate a positive response to either medication only (risperidone or aripirazole) or the combination of medication plus PMT(estimated sample size of 60) will be gradually tapered off the medication over 10 more weeks. The goal of the discontinuation phase is to compare the rate of relapse (i.e., return of tantrums, aggression and/or self-injury) across the two groups (medication only versus medication plus PMT). The justification for the inclusion of children and adolescents with PDD is based on the observation that PDD can be a serious disability across social, emotional, and academic domains. Thus, there is a pressing need for new treatments in PDD that are safe and effective.