RUPP-PI Program at Yale University

耶鲁大学 RUPP-PI 项目

基本信息

  • 批准号:
    6653041
  • 负责人:
  • 金额:
    $ 49.15万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2002
  • 资助国家:
    美国
  • 起止时间:
    2002-08-21 至 2007-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Pervasive Developmental Disorders (PDD) are serious developmental conditions affecting 6 per 1000 in school-age children. We propose a multisite 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 behavior therapy program (N=80) and then compared on adaptive and behavioral outcomes after 16 weeks. After an additional eight weeks of stabilization (6 months of treatment total), children who demonstrate 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. 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. 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that the behavioral symptoms rapidly returned in a high percentage of these pediatric patients when the medication was withdrawn in a placebo-controlled discontinuation study.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 the combination of risperidone and a structured behavior therapy program will enhance adaptive functioning in children with PDD 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 that are relevant to the conduct of clinical trials in children with PDD.
描述(由申请人提供): 广泛性发育障碍 (PDD) 是一种严重的发育疾病,每 1000 名学龄儿童中就有 6 人患有这种疾病。我们提出了一项多中心研究,其中 120 名伴有发脾气、攻击性和/或自残的 PDD 儿童将被随机分配到仅使用利培酮 (N=40) 或利培酮加结构化行为治疗计划 (N=80),然后16 周后比较适应性和行为结果。经过额外八周的稳定(总共 6 个月的治疗)后,对利培酮和行为疗法联合治疗表现出阳性反应的儿童(估计样本量为 60)将被随机分配继续利培酮治疗或逐渐停药。停药阶段的目标是检查添加行为疗法是否允许停药利培酮。将患有 PDD 的儿童和青少年纳入其中的理由是基于这样的观察:PDD 可能是跨社会、情感和学术领域的严重残疾。因此,迫切需要安全有效的 PDD 新疗法。在之前的 RUPP 自闭症网络研究中,我们表明利培酮对于伴有发脾气、攻击性和/或自残的自闭症儿童和青少年来说是安全有效的。我们还表明,在一项安慰剂对照停药研究中,当停药时,大部分儿科患者的行为症状迅速恢复。本研究将扩展这些发现,并测试利培酮和结构化行为治疗计划的结合是否会增强 PDD 儿童的适应性功能并防止复发。将仔细监测副作用和治疗反应。将对受试者进行基因分型,以评估特定血清素受体基因型与治疗反应的关系。拟议的研究将由一个多站点网络进行,该网络已经显示出在 PDD 人群中设计和进行临床试验方面的合作能力。此外,这个由五个站点组成的网络已在与 PDD 儿童临床试验相关的多项措施上建立了可靠性。

项目成果

期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Lawrence D. Scahill其他文献

Lawrence D. Scahill的其他文献

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{{ truncateString('Lawrence D. Scahill', 18)}}的其他基金

Toward Outcome Measurement of Anxiety in Youth with Autism Spectrum Disorders
自闭症谱系障碍青少年焦虑的结果测量
  • 批准号:
    8543764
  • 财政年份:
    2012
  • 资助金额:
    $ 49.15万
  • 项目类别:
Toward Outcome Measurement of Anxiety in Youth with Autism Spectrum Disorders
自闭症谱系障碍青少年焦虑的结果测量
  • 批准号:
    8421530
  • 财政年份:
    2012
  • 资助金额:
    $ 49.15万
  • 项目类别:
Toward Outcome Measurement of Anxiety in Youth with Autism Spectrum Disorders
自闭症谱系障碍青少年焦虑的结果测量
  • 批准号:
    8650951
  • 财政年份:
    2012
  • 资助金额:
    $ 49.15万
  • 项目类别:
4/4-RUPP Autism Network: Guanfacine for the Treatment of Hyperactivity in PDD
4/4-RUPP 自闭症网络:胍法辛治疗 PDD 多动症
  • 批准号:
    8098707
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
4/4-RUPP Autism Network: Guanfacine for the Treatment of Hyperactivity in PDD
4/4-RUPP 自闭症网络:胍法辛治疗 PDD 多动症
  • 批准号:
    7887234
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
1/5-Randomized Trial of Parent Training for Young Children with Autism
自闭症幼儿家长培训的 1/5 随机试验
  • 批准号:
    8204848
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
1/5-Randomized Trial of Parent Training for Young Children with Autism
自闭症幼儿家长培训的 1/5 随机试验
  • 批准号:
    8013047
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
4/4-RUPP Autism Network: Guanfacine for the Treatment of Hyperactivity in PDD
4/4-RUPP 自闭症网络:胍法辛治疗 PDD 多动症
  • 批准号:
    8237035
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
1/5-Randomized Trial of Parent Training for Young Children with Autism
自闭症幼儿家长培训的 1/5 随机试验
  • 批准号:
    8399730
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:
1/5-Randomized Trial of Parent Training for Young Children with Autism
自闭症幼儿家长培训的 1/5 随机试验
  • 批准号:
    7783088
  • 财政年份:
    2010
  • 资助金额:
    $ 49.15万
  • 项目类别:

相似海外基金

Novel Pharmacological Strategies in Autism
自闭症的新药理学策略
  • 批准号:
    7070638
  • 财政年份:
    2005
  • 资助金额:
    $ 49.15万
  • 项目类别:
Novel Pharmacological Strategies in Autism
自闭症的新药理学策略
  • 批准号:
    6865069
  • 财政年份:
    2005
  • 资助金额:
    $ 49.15万
  • 项目类别:
RUPP-PI Program at Yale University
耶鲁大学 RUPP-PI 项目
  • 批准号:
    6554735
  • 财政年份:
    2002
  • 资助金额:
    $ 49.15万
  • 项目类别:
RUPP-PI Program at Yale University
耶鲁大学 RUPP-PI 项目
  • 批准号:
    6800158
  • 财政年份:
    2002
  • 资助金额:
    $ 49.15万
  • 项目类别:
RUPP-PI Program at Yale University
耶鲁大学 RUPP-PI 项目
  • 批准号:
    7104859
  • 财政年份:
    2002
  • 资助金额:
    $ 49.15万
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