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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。该研究将包括80名诊断为精神分裂症的患者，这些患者通过使用NIMH遗传研究诊断访谈（DIGS）进行记录审查和访谈来确认。所有受试者将用一线非典型抗精神病药物（阿立哌唑除外）长期治疗>= 3个月，并从圣路易斯大都市区的社区精神健康精神病提供者招募。如果受试者选择与其治疗医生一起开始阿立哌唑试验，则受试者有资格入组。受试者将以3：1的比例随机分配，在12周研究观察期内将抗精神病药物转换为阿立哌唑，药物无其他代谢相关变化，或在12周研究观察期内暂时继续使用当前药物，并等到研究期结束后再进行药物变化。使用这种方法，将在4个组（当前利培酮治疗、当前奥氮平治疗、当前奎替鲁治疗、当前齐拉西酮治疗）中各入组22例合格受试者，其中17例受试者被分配转换为阿立哌唑治疗，5例受试者被分配继续接受当前药物治疗，作为对结局变量的非药物影响的对照条件。每组招募22例受试者，假设主要分配至转换药物的受试者的损耗率约为10%。年龄、性别、种族和糖尿病家族史的组组成将保持平衡。除了与治疗医生进行常规安排的就诊外，研究人员和精神科医生还将每周为患者进行咨询。受试者将完成基线药物的FSIVGTT和DEXA扫描，并在阿立哌唑治疗12周后（或对于未转换药物的受试者，在当前治疗额外12周后）重复这些评估。在研究评估之前，所有受试者将由GCRC注册营养师评估近期饮食摄入量。对于每次FSIVGTT，受试者将在空腹条件下被运送至GCRC。将获得基线和转换后12周的症状评级、锥体外系症状和其他主要不良事件评估。