RUPP-PI Project

RUPP-PI项目

• 批准号: 6554732
• 负责人: MICHAEL George AMAN
• 金额: $ 50.42万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6554732
• 关键词: adolescence (12-20); antidepressants; antipsychotic agents; attention deficit disorder; behavior therapy; behavioral /social science research tag; child behavior disorders; clinical research; combination therapy; cooperative study; developmental disease /disorder; genotype; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; middle childhood (6-11); patient oriented research; pharmacogenetics; pharmacokinetics; piperazines; psychological tests; psychopharmacology; risperidone; serotonin receptor; thiazoles

DESCRIPTION (provided by applicant): Pervasive Developmental Disorders (PDDs) are serious developmental conditions affecting 6 per 1000 school-age children. We propose a multisite study in which 120 children with PDDs accompanied by highly irritable behavior will be randomly assigned to risperidone only (N=40) or risperidone plus a structured behavior therapy program (N=80) and compared on adaptive and behavioral outcomes after 16 weeks. After an additional eight weeks of stabilization (6 months total), children who show a positive response to the combination of risperidone and behavior therapy (estimated samples size of 60) will be randomized to continued treatment with risperidone or gradual discontinuation. The goal of the discontinuation phase is to examine whether the addition of behavior therapy permits discontinuation of risperidone without relapse. PDD can be a profound disability across social, emotional, and academic domains. Thus, there is a pressing need for new treatments in PDD that are safe and effective. In a previous RUPP Autism Network study, we showed that risperidone was safe and effective for children and adolescents with autism accompanied by tantrums, aggression, and/or self-injury. We also showed that the behavioral symptoms rapidly returned in a high percentage of these pediatric patients when the medication was withdrawn in a placebo-controlled discontinuation study. The present study will extend these findings and will test whether risperidone plus behavior therapy will enhance adaptive functioning in children with PDDs and protect against relapse. Side effects and therapeutic response will be carefully monitored. Subjects will be genotyped in order to evaluate the relationship of specific serotonin receptor genotypes and treatment response. The proposed study will be conducted by a multisite network that has already shown the capacity to collaborate in the design and conduct of clinical trials in the PDD population. Furthermore, this five-site network has established reliability on several measures relevant to the multi-site clinical trials in children with PDD. O.S.U. also plans two pilot studies: (a) a randomized clinical trial in 60 children with PDDs and severe ADHD behavior and (b) a study of ziprasidone in 30 children and adolescents with PDDs and highly irritable behaviors.

描述（由申请人提供）：普遍的发育障碍（PDD）是严重的发育状况，影响每1000名学龄儿童6个。我们提出了一项多站点研究，其中120名PDD伴随着高度易怒行为的儿童将仅随机分配给利培酮（n = 40）或利培酮以及结构化行为疗法计划（n = 80），并在16之后进行自适应和行为结果进行比较。几周。在稳定八周（总共6个月）之后，对利培酮和行为疗法（估计的样本尺寸为60）表现出阳性反应的儿童将随机分配，以利培酮或逐渐停药的持续治疗。中断阶段的目的是检查行为疗法的添加是否允许在不复发的情况下停用利培酮。 PDD可以是社会，情感和学术领域的深刻残疾。因此，在PDD中迫切需要安全有效的治疗方法。在先前的RUPP自闭症网络研究中，我们表明利培酮对患有自闭症的儿童和青少年安全有效，伴随着发脾气，侵略和/或自我伤害。我们还表明，当在安慰剂对照的停职研究中撤出药物时，这些小儿患者中很大一部分的行为症状迅速恢复。本研究将扩展这些发现，并将测试利培酮加行为疗法是否会增强PDD儿童的适应性功能并防止复发。副作用和治疗反应将仔细监测。为了评估特定5-羟色胺受体基因型与治疗反应的关系，将对受试者进行基因分型。拟议的研究将由多站点网络进行，该网络已经显示出在PDD人群中进行临床试验的设计和进行的能力。此外，这个五个站点网络已经建立了与PDD儿童的多站点临床试验相关的多种措施的可靠性。 O.S.U.还计划了两项试点研究：（a）60名PDD儿童和严重的ADHD行为的随机临床试验，以及（b）对30名PDD和高度易怒行为的30名儿童和青少年进行Ziprasidone的研究。