Divalproex sodium & Risperidone in Pediatric Bipolar Dis

双丙戊酸钠

• 批准号: 6674834
• 负责人: Mani N Pavuluri
• 金额: $ 14.74万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6674834
• 关键词: adolescence (12-20); amygdala; antipsychotic agents; bipolar depression; child mental disorders; clinical research; clinical trials; functional magnetic resonance imaging; human subject; human therapy evaluation; middle childhood (6-11); patient oriented research; pediatric pharmacology; prefrontal lobe /cortex; risperidone; valproate

DESCRIPTION (provided by applicant): Pediatric bipolar disorder (PBD) is increasingly recognized, poorly understood, and ineffectively treated. With newly available fMRI technology, the field has matured for use in children to examine underlying brain dysfunction and treatment effects in PBD. There are very few investigators in the field trained to integrate clinical trials with fMRI methods. This career (K23) award will permit the candidate to develop as an independent clinical investigator to fill this void. The project described below serves as a medium to learn new skills under the mentorship of active, senior clinical investigators and will also allow her to take part in didactic training by protecting her time for these activities. The proposal reflects the need to bring a multidisciplinary approach to clinical research, particularly in the area of pediatric psychiatric research. Thus, the plan emphasizes pharmacotherapy, clinical trial methodology, statistics, ethics, and brain imaging using fMRI. The plan includes regular supervision by her primary mentors, interactions with internal and external-consultants and attendance at relevant didactic courses. Drs. Janicak and Sweeney will be the primary mentors. The study described in this application will examine treatment effects on the disturbances of affective circuitry hypothesized to underlie PBD. Specifically, the central aim is to conduct a double-blind, randomized clinical trial to test the hypothesis that the novel antipsychotic, risperidone, will have a rapid onset of action and efficacy at least comparable to divalproex sodium in the treatment of mixed and manic episodes of PBD. A pilot study, using a subset of subjects, will investigate whether activity in the amygdala and prefrontal cortex (PFC) underlies dysfunction in the affective circuitry of PBD and whether effective treatment normalizes any aberrant activity. During five years, 40 outpatient subjects with PBD manic or mixed episodes, ages 8-17 years, referred to the UI Pediatric Mood Disorder Clinic will be recruited.

描述（由申请人提供）： 小儿双相情感障碍（PBD）越来越多地认识到，了解不足和无效治疗。借助新近获得的功能磁共振成像技术，该领域已成长为儿童，以检查PBD中潜在的脑功能障碍和治疗效果。 该领域的研究人员很少受过培训，可以将临床试验与fMRI方法整合在一起。 这项职业（K23）奖将使候选人成为独立的临床研究者，以填补这一空白。下面描述的项目是在活跃的高级临床研究人员的指导下学习新技能的一种媒介，还将使她能够通过保护这些活动的时间参加教学培训。 该提案反映了为临床研究带来多学科方法的必要性，尤其是在儿科精神病研究领域。 因此，该计划强调了使用fMRI的药物治疗，临床试验方法，统计学，伦理和大脑成像。 该计划包括她的主要导师的定期监督，与内部和外部召集人的互动以及参加相关的教学课程。 博士。 Janicak和Sweeney将是主要导师。 本应用中描述的研究将检查对假设PBD基础的情感电路干扰的治疗效果。 具体而言，中心目的是进行一项双盲，随机的临床试验，以检验以下假设：新型抗精神病药物（利培酮）将在处理PBD的混合和躁狂发作时至少与Divalproex钠的作用和功效快速发作。 一项使用受试者子集的初步研究将研究杏仁核和额叶皮层（PFC）的活性是否是PBD情感回路中功能障碍的基础，以及有效治疗是否归一化。 在五年中，将招募40名患有PBD躁狂或混合发作的门诊受试者，年龄在8-17岁之间，提到了UI儿科情绪障碍诊所。