Acute Pharmacotherapy of Late-Life Mania

晚年躁狂症的急性药物治疗

• 批准号: 6927548
• 负责人: LAUREN B MARANGELL
• 金额: $ 18.48万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6927548
• 关键词: antipsychotic agents; behavior therapy; behavioral /social science research tag; bipolar depression; clinical research; clinical trials; cooperative study; cyclothymia; drug adverse effect; functional ability; geriatrics; human old age (65+); human subject; human therapy evaluation; lithium; mental disorder chemotherapy; patient oriented research; psychological aspect of aging; psychopathology; quality of life; serotonin inhibitor; tremor; valproate

DESCRIPTION (provided by applicant): Elders with bipolar disorders (BP) have severe and debilitating psychopathology, poor treatment outcomes, and high medical morbidity and mortality. Controlled treatment studies for late-life BP disorder are lacking, and findings in young patients may not be relevant because aging-related changes may reduce the tolerability and efficacy of treatments. Improving the treatment of late-life BP disorder was identified as a priority at the NIMH-DBPA Consensus Conference (2001). In response, we propose the first randomized, double-blind, controlled comparison of lithium (LI) and divalproex (DV) in elders with BP-I manic, mixed and hypomanic episodes, designed to test differences in side effects and benefits under dosing conditions relevant to geriatric practice. Hospitalized and ambulatory patients (n=306) aged 60 years and older will be studied for 9 weeks. Participants will be randomized to LI (0.4-0.99 mEq/L; target 0.80-0.99 mEq/L) or DV (valproate 40-99 meg/ml; target 80-99 meg/ml), and will be treated with monotherapy in the first three weeks at maximum tolerated concentrations. Patients with unsatisfactory response after three weeks will receive adjunctive olanzapine. The tolerability measures will be side effect ratings and the proportion treated at target concentrations. The efficacy measures will be improvement in mood symptoms and in function and quality of life. Data obtained for testing the primary hypotheses will allow secondary analyses of selected factors which may modify outcomes. Compatibility of selected measures with those of the STEP-BD study of younger patients will enhance the value of findings from this study. Recognizing the difficulties inherent in a randomized study of BP elders, we brought together six groups (Cornell, Baylor College of Medicine, Case Western Reserve, Duke, and Universities of Pennsylvania and Pittsburgh) with research expertise in late-life and young adult BP disorders, and with strong research infrastructure and clinical resources. The sites have a history of successful collaborative research, including demanding geriatric studies.

描述（由申请人提供）：患有双相情感障碍（BP）的老年人患有严重且令人衰弱的精神病理学、治疗结果不佳以及较高的医疗发病率和死亡率。缺乏针对晚年血压疾病的对照治疗研究，并且年轻患者的研究结果可能不相关，因为与衰老相关的变化可能会降低治疗的耐受性和疗效。 NIMH-DBPA 共识会议（2001 年）将改善晚期血压疾病的治疗确定为优先事项。为此，我们提出了首次对患有 BP-I 躁狂、混合和轻躁狂发作的老年人进行锂 (LI) 和双丙戊酸钠 (DV) 的随机、双盲、对照比较，旨在测试剂量条件下副作用和益处的差异与老年医学实践相关。 60 岁及以上的住院和门诊患者 (n=306) 将接受为期 9 周的研究。参与者将被随机分配至 LI（0.4-0.99 mEq/L；目标 0.80-0.99 mEq/L）或 DV（丙戊酸 40-99 meg/ml；目标 80-99 meg/ml），并将在最大耐受浓度的前三周。三周后反应不满意的患者将接受奥氮平辅助治疗。耐受性测量将是副作用评级和在目标浓度下治疗的比例。疗效指标将是情绪症状、功能和生活质量的改善。用于检验主要假设的数据将允许对可能改变结果的选定因素进行二次分析。所选措施与针对年轻患者的 STEP-BD 研究的兼容性将提高本研究结果的价值。认识到对血压老年人进行随机研究固有的困难，我们汇集了六个在晚年和年轻成人血压疾病方面具有研究专业知识的小组（康奈尔大学、贝勒医学院、凯斯西储大学、杜克大学以及宾夕法尼亚大学和匹兹堡大学） ，并拥有强大的研究基础设施和临床资源。这些站点有着成功合作研究的历史，包括要求严格的老年医学研究。