ARIPIPRAZOLE IVGTT

阿立哌唑 IVGTT

• 批准号: 7377218
• 负责人: JOHN W. NEWCOMER
• 金额: $ 2.54万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377218
• 关键词: ARIPIPRAZOLE; IVGTT

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. The study will include 80 patients diagnosed with schizophrenia, confirmed by record review and interview using the NIMH Diagnostic Interview for Genetic Studies (DIGS). All subjects will be chronically treated with front-line atypical antipsychotic medications other that aripiprazole for >= 3 months, and recruited from community mental health psychiatric providers in St. Louis metropolitan area. Subjects will be eligible for enrollment if they elect with their treating physician to begin a trial of aripiprazole. Subjects will be randomized in a 3:1 ratio to switch antipsychotic medication to aripiprazole during the 12-week study observation period with no other metabolically relevant changes in medications, or to temporarily continue their current medication durng the 12-week study observation period and wait until after the study period to pursue their change in medication. Using this approach, 22 eligible subjects in each of 4 groups (current risperidone treatment, current olanzapine treatment, current quetiapine treatment, current ziprasidone treatment) will be enrolled, with 17 subjects assigned to switch to aripiprazole, and 5 assigned to stay on current medication as a control condition for non-medication effects on outcome variables. Recruitment will targe 22 subjects per group, assuming approximately 10% attrition rate primarily in the subjects assigned to switch medications. Group composition will be balanced for age, gender ethnicity and family history of diabetes mellitus. In addition to ongoing routinely scheduled visits with the treating physician, research staff and psychiatrists will see patients weekly on a consultation basis. Subjects will complete an FSIVGTT and DEXA scan on their baseline medication and repeat these assessments after 12 weeks of aripiprazole therapy (or after an additional 12 weeks on their current therapy for those subjects who do not switch medication). Prior to study assessments, all subjects will have recent dietary intake assessed by GCRC registered dieticians. Subjects will be transported to the GCRC under fasting conditions for each FSIVGTT. Baseline and 12 week post-switch assessments of sympton ratings, extrapyramidal symptoms and other major adverse events will be obtained.

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。这项研究将包括80名被诊断为精神分裂症的患者，他们通过NIMH遗传学研究诊断访谈(DIGS)的记录回顾和采访得到确认。所有受试者将接受阿立哌唑以外的一线非典型抗精神病药物的长期治疗，为期3个月，并从圣路易斯大都市地区的社区精神卫生精神科提供者那里招募。如果受试者选择与他们的主治医生一起开始阿立哌唑的试验，他们将有资格参加登记。受试者将按3：1的比例随机分组，在12周的研究观察期内将抗精神病药物转换为阿立哌唑，而药物没有其他代谢相关的变化，或者在12周的研究观察期内暂时继续他们目前的药物治疗，并等到研究结束后再继续他们的药物改变。采用这种方法，将纳入4组(当前利培酮治疗、当前奥氮平治疗、当前奎硫平治疗、当前齐拉西酮治疗)每组中的22名符合条件的受试者，其中17名受试者被分配到改用阿立哌唑，5名受试者被分配继续接受当前药物治疗，作为非药物治疗对结果变量影响的对照条件。招募将达到每组22名受试者的目标，假设主要在被分配换药的受试者中约10%的流失率。小组成员将根据年龄、性别、种族和糖尿病家族史进行平衡。除了与治疗医生进行常规安排的访问外，研究人员和精神病学家将每周会诊一次患者。受试者将完成对他们的基线药物的FSIVGTT和DEXA扫描，并在阿立哌唑治疗12周后重复这些评估(对于那些没有更换药物的受试者，在他们目前的治疗额外12周之后)。在研究评估之前，所有受试者都将接受GCRC注册营养师的最近饮食摄入量评估。受试者将在每个FSIVGTT的禁食条件下被运送到GCRC。将获得基线和12周后对症状分级、锥体外系症状和其他主要不良事件的评估。