Metabolic Effects of Newer Antipsychotics in Older Pts

新型抗精神病药对老年患者的代谢影响

• 批准号: 6922325
• 负责人: DILIP V. JESTE
• 金额: $ 92.54万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-24 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6922325
• 关键词: aging; antipsychotic agents; behavioral /social science research tag; blood glucose; blood lipid; body composition; cardiovascular disorder risk; clinical research; clinical trials; diabetes risk; drug adverse effect; drug screening /evaluation; functional ability; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; metabolic syndrome; psychopharmacology; quality of life; risperidone; serotonin inhibitor; stroke

DESCRIPTION (provided by applicant): Since their introduction during the past decade, the newer atypical antipsychotics have been increasingly used for the management with a variety of psychotic disorders and severe behavioral disturbances in older patients, primarily because of their lower risk of extrapyramidal symptoms and tardive dyskinesia compared to conventional neuroleptics. However, in the last few years there has been a growing concern among clinicians and researchers that these medications may present a different set of potentially serious adverse effects, especially long-term Metabolic, Cardiovascular, and Cerebrovascular Effects (MCCE) resulting in weight gain, type 2 diabetes mellitus, hyperlipidemia, and strokes. The goal of the proposed project is to evaluate the risk of MCCE of 4 atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and risperidone), the mediators and moderators of MCCE, and the impact of these side effects on everyday functioning and quality of life in middle-aged and elderly psychiatric patients. This will be a longitudinal, prospective study with serial clinical and laboratory assessments. The strengths of this proposal include its public health importance, use of Equipoise-Stratified randomization (which is scientifically, ethically, and practically superior to the conventional randomization), state-of-the-art clinical and laboratory assessments of MCCE, plans for data sharing that take into account patient's right to confidentiality, an experienced multidisciplinary team of investigators (including experts in metabolic, cardiovascular, and cerebrovascular disorders), and infrastructure support provided by an NIMH-funded Advanced Center for Interventions and Services Research (including its Operations Core, Bioethics Unit, and Methodology, Biostatistics & Data Management Unit) as well as an NIH-supported General Clinical Research Center.

描述（由申请人提供）：自从他们在过去十年中引入他们的引入以来，越来越多地将新的非典型抗精神病药用于治疗，患有多种精神病性疾病和老年患者的严重行为障碍，这主要是因为与传统的神经感相比，它们较低的锥体外症状风险和tard炎的风险较低。然而，在过去的几年中，临床医生和研究人员越来越关注这些药物可能会带来不同的潜在严重不良反应，尤其是长期代谢，心血管和脑血管效应（MCCE），导致体重增加，导致2型糖尿病型糖尿病，高脂症，高脂血症和中曲。拟议项目的目的是评估4种非典型抗精神病药（Aripiprazole，Olanzapine，Quetiapine和Risperpidone），MCCE的介体和主持人的MCCE风险，以及这些副作用对中年和老年人生活的日常功能和生活质量的影响。这将是一项纵向前瞻性研究，并进行了串行临床和实验室评估。 The strengths of this proposal include its public health importance, use of Equipoise-Stratified randomization (which is scientifically, ethically, and practically superior to the conventional randomization), state-of-the-art clinical and laboratory assessments of MCCE, plans for data sharing that take into account patient's right to confidentiality, an experienced multidisciplinary team of investigators (including experts in metabolic, cardiovascular, and cerebrovascular disorders), and由NIMH资助的干预和服务研究高级中心提供的基础设施支持（包括其运营核心，生物伦理学单元和方法论，生物统计学和数据管理部门）以及NIH支持的一般临床研究中心。