ARIPIPRAZOLE IVGTT

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究将包括80名被诊断为精神分裂症的患者，通过记录审查和使用NIMH遗传研究诊断访谈（DIGS）的访谈得到证实。所有受试者将从圣路易斯大都会地区的社区精神卫生精神科服务提供者中招募，长期使用阿立哌唑以外的一线非典型抗精神病药物治疗100 = 3个月。如果受试者与治疗医师一起选择开始阿立哌唑试验，受试者将有资格入组。受试者将按3:1的比例随机分配，在12周的研究观察期内将抗精神病药物转换为阿立哌唑，并且没有其他与代谢相关的药物变化，或者在12周的研究观察期内暂时继续使用当前的药物，并等到研究期结束后再进行药物变化。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、当前喹硫平治疗、当前齐拉西酮治疗）中每组22名符合条件的受试者，其中17名受试者被分配改用阿立哌唑，5名受试者被分配继续使用当前药物，作为非药物对结果变量影响的对照条件。招募将针对每组22名受试者，假设大约10%的损失率主要是分配到转换药物的受试者。小组组成将根据年龄、性别、种族和糖尿病家族史进行平衡。除了定期与主治医生进行例行访问外，研究人员和精神科医生将每周在咨询的基础上为患者进行检查。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周后重复这些评估（或未转换药物的受试者在当前治疗12周后重复这些评估）。在研究评估之前，GCRC注册营养师将评估所有受试者最近的饮食摄入量。受试者将在每次FSIVGTT的禁食条件下被运送到GCRC。将获得基线和转换后12周的症状评分、锥体外系症状和其他主要不良事件的评估。

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.