CLINICAL TRIAL: RISPERIDONE AND BEHAVIOR THERAPY IN CHILDREN WITH PDD

临床试验：PDD 儿童的利培酮和行为疗法

• 批准号: 7718622
• 负责人: MICHAEL George AMAN
• 金额: $ 0.94万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718622
• 关键词: Adaptive Behaviors; Aggressive behavior; Behavior Therapy; Child; Clinical Trials; Compliant Behaviors; Computer Retrieval of Information on Scientific Projects Database; Daily; Funding; Grant; Institution; Life; Measures; Parents; Pharmaceutical Preparations; Randomized Controlled Clinical Trials; Rate; Relapse; Research; Research Personnel; Resources; Risperidone; Self-Injurious Behavior; Source; Training; United States National Institutes of Health; Week; discontinuation trial; follow-up; skills; treatment effect

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. 1) to compare the benefits of risperidone only to risperidone + parent management training (PMT) on a measure of non-compliant behavior in children with PDD accompanied by tantrums, aggression, and/or self injury ("high irritability") in a 24-week randomized trial. 2) to compare the benefits of risperidone only to risperidone + PMT on adaptive behavior (daily living skills) in children with PDD and high irritability in a 24-week randomized trial. 3) to compare the rate of relapse when the medication is gradually withdrawn in a 10-week discontinuation trial in children treated successfully for up to 24 weeks with medication only or medication + PMT. 4) to evaluate enduring effects of these treatments at follow-up 20 months after study entry.

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。 1)在一项为期24周的随机试验中，比较单独服用利培酮和利培酮+父母管理培训(PMT)对伴有发脾气、攻击性和/或自我伤害(“高度易怒”)的PDD儿童的不依从行为的影响。2)在一项为期24周的随机试验中，比较单独服用利培酮和利培酮+PMT对患有PDD和高度易怒儿童的适应行为(日常生活技能)的益处。3)比较在为期10周的停药试验中，单纯药物治疗或药物+PMT治疗成功长达24周的儿童在逐渐停药时的复发率。4)在研究开始后20个月的随访中评估这些治疗的持久效果。