DIVALPROEX SODIUM ER IN ADULT AUTISM

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。 基于双丙戊酸钠在自闭症儿童/青少年中的积极研究，我们希望将该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人。 我们的目的是有10名成年自闭症患者参加我们的研究治疗的攻击/易怒与双丙戊酸钠ER。 这将是成人患者的开放治疗，因为先前的研究已经涉及双盲双丙戊酸钠与安慰剂设计。 这种自然主义设计将允许既往稳定（3个月）使用伴随药物。 我们的目的是确定这些患者对处方剂量的耐受程度以及双丙戊酸钠ER的额外获益。 将根据ABC、CGI和OAS-M易怒量表评估患者易怒/攻击性的改善。 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. 证明与基线相比，全球严重程度评分有所改善 2. 证明冲动性攻击性相对于基线下降有所改善。 3. 证明与基线相比，评分和情感不稳定性有所改善。

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.