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) 越来越受到人们的认识、了解和治疗无效。凭借新推出的功能磁共振成像技术，该领域已经成熟，可用于儿童检查 PBD 的潜在脑功能障碍和治疗效果。 该领域很少有研究人员接受过将临床试验与功能磁共振成像方法相结合的培训。 该职业 (K23) 奖项将使候选人能够发展成为一名独立的临床研究者，以填补这一空白。下面描述的项目作为在活跃的高级临床研究人员的指导下学习新技能的媒介，并且还允许她通过保护她的这些活动时间来参加教学培训。 该提案反映了将多学科方法引入临床研究的必要性，特别是在儿科精神病学研究领域。 因此，该计划强调药物治疗、临床试验方法、统计学、伦理学和使用功能磁共振成像的脑成像。 该计划包括她的主要导师的定期监督、与内部和外部顾问的互动以及参加相关的教学课程。 博士。 Janicak 和 Sweeney 将担任主要导师。 本申请中描述的研究将检查对假设为 PBD 基础的情感回路紊乱的治疗效果。 具体来说，中心目标是进行一项双盲、随机临床试验，以检验这样的假设：新型抗精神病药利培酮在治疗混合型和躁狂发作方面起效快，疗效至少与双丙戊酸钠相当。的PBD。 一项试点研究使用了一部分受试者，将调查杏仁核和前额皮质 (PFC) 的活动是否是 PBD 情感回路功能障碍的基础，以及有效的治疗是否可以使任何异常活动正常化。 在五年内，将招募 40 名患有 PBD 躁狂或混合发作的门诊受试者，年龄为 8-17 岁，转诊至 UI 儿科情绪障碍诊所。