Acute Pharmacotherapy of Late-Life Mania

晚年躁狂症的急性药物治疗

• 批准号: 7673299
• 负责人: Martha X Sajatovic
• 金额: $ 24.04万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 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 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7673299
• 关键词: Accounting; Acute; Adverse effects; Age; Behavior Therapy; Bipolar Depression; Bipolar Disorder; Body Weight; Clinical; Clinical dementia rating scale; Comorbidity; Complex; Confusion; Consensus; DSM-IV; Data; Delirium; Diarrhea; Disease; Disorientation; Dose; Double-Blind Method; Elderly; Generations; Impaired cognition; Impairment; Inpatients; Intervention; Life; Lithium; Living Wills; Manic; Measures; Mediating; Medical; Medicine; Metabolic syndrome; Mood stabilizers; Moods; Morbidity - disease rate; National Institute of Mental Health; Nausea; Outcome; Participant; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Plasma; Protocols documentation; Psychopathology; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Resistance; Resources; Sedation procedure; Services; Site; Symptoms; Tardive Dyskinesia; Testing; Therapeutic; Treatment Efficacy; Treatment Protocols; Treatment outcome; Tremor; Uncontrolled Study; Universities; Valproic Acid; age related; aging brain; base; clinical care; college; comparative efficacy; design; disability; dosage; expectation; falls; gastrointestinal; improved; instrumental activity of daily living; mortality; olanzapine; older patient; programs; response; symposium; trial comparing; valproate; young adult; Accounting; Acute; Adverse effects; Age; Behavior Therapy; Bipolar Depression; Bipolar Disorder; Body Weight; Clinical; Clinical dementia rating scale; Comorbidity; Complex; Confusion; Consensus; DSM-IV; Data; Delirium; Diarrhea; Disease; Disorientation; Dose; Double-Blind Method; Elderly; Generations; Impaired cognition; Impairment; Inpatients; Intervention; Life; Lithium; Living Wills; Manic; Measures; Mediating; Medical; Medicine; Metabolic syndrome; Mood stabilizers; Moods; Morbidity - disease rate; National Institute of Mental Health; Nausea; Outcome; Participant; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Plasma; Protocols documentation; Psychopathology; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Resistance; Resources; Sedation procedure; Services; Site; Symptoms; Tardive Dyskinesia; Testing; Therapeutic; Treatment Efficacy; Treatment Protocols; Treatment outcome; Tremor; Uncontrolled Study; Universities; Valproic Acid; age related; aging brain; base; clinical care; college; comparative efficacy; design; disability; dosage; expectation; falls; gastrointestinal; improved; instrumental activity of daily living; mortality; olanzapine; older patient; programs; response; symposium; trial comparing; valproate; young adult

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）：患有躁郁症（BP）的长老患有严重且令人衰弱的心理病理学，治疗效果不佳以及医疗发病率高和死亡率。缺乏针对BP疾病的对照治疗研究，年轻患者的发现可能无关紧要，因为与衰老相关的变化可能会降低治疗的耐受性和功效。在NIMH-DBPA共识会议（2001）中，改善晚期BP疾病的治疗被确定为优先事项。作为回应，我们提出了第一个随机，双盲，受控的比较锂（Li）和Divalproex（DV）在具有BP-I躁狂，混合和易感性发作的长者中，旨在测试与老年练习相关的副作用及其副作用的差异。将研究9周及60岁以上的住院和门诊患者（n = 306）。参与者将被随机分为LI（0.4-0.99 MEQ/L;目标0.80-0.99 MEQ/L）或DV（瓣膜40-99兆/mL;目标80-99 meg/ml），并将以最大耐受浓度在前三周用单疗法治疗。三周后反应不足的患者将接受辅助奥氮平。耐受性度量将是副作用评级，并且在目标浓度下处理的比例。功效措施将改善情绪症状以及生活质量和生活质量。获得用于测试主要假设的数据将允许对可能改变结果的选定因素进行次要分析。选定的措施与年轻患者的继BD研究的兼容性将提高本研究的发现价值。认识到BP长老的随机研究所固有的困难，我们将六组（康奈尔大学，贝勒医学院，案例西部保护区，杜克大学，杜克大学和宾夕法尼亚州和匹兹堡大学）与后期的成人BP疾病以及强大的研究基础结构和临床资源一起进行了研究专业知识。这些站点有成功的合作研究历史，包括苛刻的老年研究。