Ginkgo biloba for ECT-induced Memory Deficits

银杏叶治疗 ECT 引起的记忆缺陷

• 批准号: 6608184
• 负责人: JOHN S MARKOWITZ
• 金额: $ 18.25万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-15 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6608184
• 关键词: alternative medicine; behavioral /social science research tag; clinical research; cognition disorders; drug administration rate /duration; drug adverse effect; drug screening /evaluation; drug tolerance; electroconvulsive therapy; electroencephalography; electromyography; ginkgo biloba; human subject; human therapy evaluation; major depression; medical complication; memory disorders; neuropsychological tests; placebos; quality of life; short term memory; therapy compliance

DESCRIPTION (provided by applicant): Background: Electroconvulsive therapy (ECT) is a safe and effective modern treatment for severe depression and other specific psychiatric conditions. Although typically reserved for a subset of patients with the most severe illnesses and who have failed initial medication trials, an estimated 100,000 treatments occur per year in the US, and 1,000,000 per year worldwide with use increasing. ECT's most bothersome adverse effect is memory loss with all patients receiving ECT experiencing some degree of short term cognitive impairment. At present there are no known effective pharmacologic treatments to prevent or improve ECT-induced cognitive dysfunction. The herbal preparation Ginkgo biloba (GB) has been found, in a promising series of recent studies, to aid cognitive function and memory in both dementia and in normal volunteers. In the present proposal, we will investigate the utility and safety of GB to minimize the cognitive impairment typically associated with ECT. Specific Aims: To assess the effect of GB in reducing the adverse cognitive effects of ECT, 2) To assess the safety and tolerability of GB. Research Design: The proposed double-blind, placebo-controlled, parallel design study will be carried out over a two year period in 40 patients and will assess the effectiveness and safety of a standardized form of GB (EGb 761,Teboninr) manufactured by Dr. Willmar Schwabe GmbH & Co. in a dose of 120 mg twice daily versus placebo in reducing the cognitive side effects of ECT treatment. Patients will begin taking active drug or placebo as soon as consent is obtained and baseline testing is completed, in an attempt to reach steady-state plasma levels of GB prior to ECT. Patients will undergo cognitive testing by a blinded rater in the three relevant domains of cognitive function (anterograde memory, retrograde memory, and acute orientation) at specified intervals following ECT. Groups will then be compared on measures of cognitive function, and the active drug group will be compared with published data regarding the memory effects of ECT. A standardized side effect scale will be employed to assess the tolerability of GB versus placebo. Future Studies: If, in this exploratory study it is found that GB exerts a protective effect on memory function in patients receiving ECT, future studies will utilize larger groups and additional cognitive tests will be incorporated to provide more definitive conclusions regarding efficacy, optimal dose and duration, persistence of effects, and safety and tolerability

描述（由申请人提供）：背景：电磁治疗（ECT）是针对严重抑郁症和其他特定精神疾病的安全有效的现代疗法。 尽管通常保留给最严重疾病且初始药物试验失败的一部分，但估计每年进行100,000次治疗，每年每年有100万次治疗，随着使用的使用增加。 ECT最麻烦的不良反应是记忆力丧失，所有接受ECT的患者经历了一定程度的短期认知障碍。 目前，尚无已知的有效药理治疗方法来预防或改善ECT诱导的认知功能障碍。在一系列有希望的最近研究中，发现了草药制剂银杏鸟（GB），以帮助痴呆症和正常志愿者中的认知功能和记忆。 在本提案中，我们将研究GB的效用和安全性，以最大程度地减少通常与ECT相关的认知障碍。 具体目的：评估GB在降低ECT不良认知效果方面的影响，2）评估GB的安全性和耐受性。 研究设计：提议的双盲，安慰剂对照，并行设计研究将在40名患者的两年内进行，并将评估Willmar Schwabe Gmbh＆Co.博士制造的标准化形式的GB（EGB 761，TEBONINR）的有效性和安全性。 一旦获得同意，患者将开始服用活跃的药物或安慰剂，并完成基线测试，以尝试在ECT之前达到GB的稳态血浆水平。 患者将在ECT之后的指定间隔中以特定的间隔进行认知功能的三个相关领域（顺行记忆，逆行记忆和急性方向）进行认知评估者的认知测试。 然后，将根据认知功能的度量进行比较组，并将活动药物组与有关ECT记忆效应的已发表数据进行比较。 将采用标准化的副作用量表来评估GB与安慰剂的耐受性。 Future Studies: If, in this exploratory study it is found that GB exerts a protective effect on memory function in patients receiving ECT, future studies will utilize larger groups and additional cognitive tests will be incorporated to provide more definitive conclusions regarding efficacy, optimal dose and duration, persistence of effects, and safety and tolerability