ARIPIPRAZOLE IVGTT

阿立哌唑 IVGTT

• 批准号: 7603333
• 负责人: JOHN W. NEWCOMER
• 金额: $ 0.87万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603333
• 关键词: Adverse event; Age; Antipsychotic Agents; Area; Communities; Computer Retrieval of Information on Scientific Projects Database; Condition; Consultations; DEXA; Diabetes Mellitus; Diagnosis; Diagnostic; Dietary intake; Enrollment; Equilibrium; Ethnic Origin; Family history of; Fasting; Funding; Gender; Genetic; Grant; Institution; Interview; Mental Health; National Institute of Mental Health; Outcome; Patients; Pharmaceutical Preparations; Physicians; Provider; Psychiatrist; Randomized; Rate; Recruitment Activity; Research; Research Personnel; Resources; Risperidone; Scanning; Schedule; Schizophrenia; Source; Symptoms; United States National Institutes of Health; Visit; Week; aripiprazole; atypical antipsychotic; base; metropolitan; olanzapine; quetiapine; ziprasidone

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 该研究将包括 80 名被诊断患有精神分裂症的患者，并通过记录审查和使用 NIMH 基因研究诊断访谈 (DIGS) 进行访谈来确认。 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长期治疗≥3个月，并从圣路易斯大都市区的社区心理健康精神病学提供者中招募。 如果受试者选择与治疗医生一起开始阿立哌唑试验，则他们将有资格参加。 受试者将按照 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换为阿立哌唑，且药物中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当前的药物治疗并等待直到研究期结束后才继续改变药物治疗。 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）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 名被分配继续使用当前药物治疗作为非药物对结果变量影响的控制条件。 招募将针对每组 22 名受试者，假设主要在分配转换药物的受试者中的流失率约为 10%。 群体组成将在年龄、性别、种族和糖尿病家族史方面保持平衡。 除了定期拜访治疗医生外，研究人员和精神科医生还将每周会诊患者。 受试者将完成对其基线药物的 FSIVGTT 和 DEXA 扫描，并在阿立哌唑治疗 12 周后（或对于那些不更换药物的受试者，在当前治疗额外 12 周后）重复这些评估。 在研究评估之前，所有受试者都将接受由 GCRC 注册营养师评估的近期饮食摄入量。 每个 FSIVGTT 的受试者将在禁食条件下被运送至 GCRC。 将获得症状评级、锥体外系症状和其他主要不良事件的基线和转换后 12 周评估。