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）：自过去十年推出以来，新型非典型抗精神病药已越来越多地用于治疗老年患者的各种精神障碍和严重行为障碍，主要是因为它们出现锥体外系症状的风险较低，并且与传统抗精神病药相比，迟发性运动障碍。然而，在过去几年中，临床医生和研究人员越来越担心这些药物可能会带来一系列不同的潜在严重不良反应，特别是长期代谢、心血管和脑血管影响 (MCCE)，导致体重增加、 2 型糖尿病、高脂血症和中风。拟议项目的目标是评估 4 种非典型抗精神病药物（阿立哌唑、奥氮平、喹硫平和利培酮）的 MCCE 风险、MCCE 的调节剂和调节剂，以及这些副作用对患者日常功能和生活质量的影响。中老年精神病患者。这将是一项纵向、前瞻性研究，包括一系列临床和实验室评估。该提案的优点包括其公共卫生重要性、使用平衡分层随机化（在科学上、道德上和实践上优于传统随机化）、MCCE 的最先进的临床和实验室评估、数据计划考虑到患者保密权的共享、经验丰富的多学科研究团队（包括代谢、心血管和脑血管疾病专家）以及 NIMH 资助的高级中心提供的基础设施支持干预和服务研究（包括其运营核心、生物伦理学单位、方法学、生物统计和数据管理单位）以及 NIH 支持的综合临床研究中心。