DIVALPROEX SODIUM ER IN ADULT AUTISM

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。基于对患有自闭症的儿童/青少年使用异丙丙胺的实证研究，我们希望将这项研究扩展到具有高度攻击性、易怒、情感不稳定或激越的自闭症成年人。我们的目标是让10名成年自闭症患者参加我们的研究，即双丙戊酸钠ER治疗攻击性/易激性。这将是成人患者的一种开放治疗，因为之前的研究已经涉及双盲异丙戊酸钠和安慰剂设计。这种自然主义的设计将允许事先稳定(3个月)使用伴随药物。我们的目标是确定这些患者对处方剂量的耐受性有多好，以及异丙丙酮钠ER有哪些额外的好处。患者在易怒/攻击性方面的改善将在ABC、CGI和OAS-M易怒程度量表上进行评估。这项研究将在9个月内完成。假设：接受Depakote ER治疗的自闭症谱系障碍患者将在12周内：1.在全球严重程度评级方面比基线有所改善2.在冲动性攻击性方面比基线有所改善。3.在评级和情感不稳定方面表现出比基线有所改善。

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. Based on positive research with divalproex in children/adolescents with autism, we would like to extend this research to autistic adults with high levels of aggression, irritability, affective instability, or agitation. We aim to have 10 adult autistic patients enrolled in our study of the treatment of aggression/irritability with divalproex sodium ER. This will be an open treatment for adult patients since the previous studies already involved a double-blind divalproex sodium vs. placebo design. This naturalistic design will allow for prior stable (3 months) use of concomitant medications. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER. The patients' improvement on irritability/aggression will be assessed on the ABC, CGI, and OAS-M irritability scales. This study will be completed in nine months. Hypothesis: Patients with Autism Spectrum Disorders receiving treatment with Depakote ER will, over 12 weeks: 1. Demonstrate an improvement versus baseline on ratings of global severity 2. Demonstrate an improvement versus baseline decrease in impulsive aggression. 3. Demonstrate an improvement versus baseline on ratings and affective lability.