Efficacy of an SSRI for Menopausal Symptoms in Perimenopausal Women

SSRI 对围绝经期女性更年期症状的功效

• 批准号: 7533564
• 负责人: ELLEN W FREEMAN
• 金额: $ 31.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7533564
• 关键词: Address; Adverse effects; African American; Anxiety; Behavioral; Boston; Clinical; Clinical Trials; Coronary heart disease; Daily; Data Coordinating Center; Dementia; Depressed mood; Devices; Disruption; Distress; Dose; Double-Blind Method; Enrollment; Escitalopram; Estradiol; Estrogens; Fatigue; Frequencies; Functional disorder; Goals; Gold; Healthcare Systems; Hormonal; Hot flushes; Impaired cognition; Intervention; Lead; Link; Measures; Menopausal Symptom; Menopausal hot flushes; Menopause; Mental Depression; Monitor; Moods; Night Sweating; Numbers; Patients; Perimenopause; Pharmaceutical Preparations; Philadelphia; Placebos; Population Heterogeneity; Postmenopause; Principal Investigator; Progestins; Protocols documentation; Public Health; Quality of life; Race; Randomized; Randomized Controlled Trials; Range; Reporting; Research Personnel; Risk; Role; Safety; Scientist; Score; Selective Serotonin Reuptake Inhibitor; Serotonin; Serotonin Agents; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Staging; Standards of Weights and Measures; Stress; Stroke; Sweat; Sweating; Symptoms; System; Testing; Therapeutic; Time; Treatment Efficacy; Treatment Protocols; Vasomotor; Woman; Women' s Health; Work; body-mind; diaries; double-blind placebo controlled trial; experience; hormone therapy; improved; inhibitor/antagonist; malignant breast neoplasm; middle age; mind control; programs; racial difference; randomized placebo controlled trial; reproductive; response; reuptake

DESCRIPTION (provided by applicant): This application proposes a clinical trial within a network of scientists who are highly knowledgeable about the menopausal transition and experienced in the conduct of women's health trials in order to fulfill the main objective of this RFA, which is to accelerate the identification of effective remedies to relieve vasomotor symptoms. This application is submitted in conjunction with the network titled "The Menopausal Symptoms Initiative - Finding Lasting Answers to Sweats and Hot Flashes" (MSI-FLASH). The Data Coordinating Center (DCC) of the network is led by A. LaCroix and G. Anderson, who have served as Co-Principal Investigators of the Women's Health, Initiative, Clinical Coordinating Center (Seattle) for more than a decade. The MSI-FLASH network has 5 clinical field sites located in Boston (L. Cohen and H. Jaffe, PIs), Indianapolis (J Carpenter, PI),Oakland, CA (B Sternfeld and B Caan, PIs),Philadelphia (E. Freeman, PI) and Seattle (K Newton and S Reed, PIs). This multi disciplinary investigator group proposes 5 randomized controlled trials that test a range of behavioral, mind-body, hormonal and pharmacologic interventions for menopausal hot flashes. This field site proposes a randomized, placebo-controlled trial to determine the efficacy of a serotonergic reuptake inhibitor (SSRI) for reducing hot flashes associated with menopause and determine the effects of known covariates of hot flashes in treatment response. The specific aims are to 1) Determine the efficacy of the SSRI escitalopram compared with placebo in reducing the frequency, severity and bothersomeness of hot flashes; 2) Determine associations of baseline measures of anxiety, depressed mood, poor sleep, perceived stress, menopausal stage and race with improvement of hot flashes; 3) Determine whether changes in anxiety and depressed mood during treatment are associated with decreases in hot flashes with escitalopram compared to placebo; 4) Determine the time course for improvement of hot flashes with escitalopram compared to placebo. Approximately 180 women will be randomized to double-blind treatment, and enrollment will be stratified to obtain equal numbers of African American and white women. It is expected that 3 other field sites of the Network will also conduct this protocol, providing a collaborative and multi disciplinary approach, diverse populations and a rapid completion of the treatment protocol. Increased information about treatment efficacy and the factors associated with treatment response, including whether there are racial differences in response to treatment, will lead to better therapeutic strategies for women who experience distressing and disruptive menopausal symptoms. Information about responses to a serotonergic treatment may increase understanding of associations between hot flashes and the serotonergic system.

描述（由申请人提供）：本申请提出了一项临床试验，该临床试验由一群对更年期过渡非常了解并在进行妇女健康试验方面经验丰富的科学家组成，以实现本RFA的主要目标，即加速确定缓解血管舒缩症状的有效补救措施。该申请是与题为“更年期症状倡议-寻找出汗和潮热的持久答案”（MSI-FLASH）的网络一起提交的。该网络的数据协调中心（DCC）由a . LaCroix和G. Anderson领导，他们担任妇女健康倡议临床协调中心（西雅图）的联合首席调查员已有十多年了。MSI-FLASH网络有5个临床现场站点，分别位于波士顿（L. Cohen和H. Jaffe， PI）、印第安纳波利斯（J Carpenter， PI）、加利福尼亚州奥克兰（B Sternfeld和B Caan， PI）、费城（E. Freeman， PI）和西雅图（K Newton和S Reed， PI）。这个多学科研究小组提出了5个随机对照试验，测试一系列行为、身心、激素和药物干预绝经期潮热。本研究提出了一项随机、安慰剂对照试验，以确定血清素能再摄取抑制剂（SSRI）减少与更年期相关的潮热的疗效，并确定治疗反应中已知潮热协变量的影响。具体目的是：1)确定与安慰剂相比，SSRI艾司西酞普兰在减少潮热频率、严重程度和困扰方面的疗效；2)确定焦虑、抑郁情绪、睡眠不良、感知压力、绝经期和种族的基线测量与潮热改善的关系；3)与安慰剂相比，确定治疗期间焦虑和抑郁情绪的变化是否与艾司西酞普兰减少潮热有关；4)确定艾司西酞普兰与安慰剂相比改善潮热的时间过程。大约180名妇女将被随机分配到双盲治疗中，并将分层登记，以获得相同数量的非裔美国人和白人妇女。预计该网络的其他3个外地站点也将执行该方案，提供协作和多学科方法、不同人群和快速完成治疗方案。更多关于治疗效果和治疗反应相关因素的信息，包括对治疗的反应是否存在种族差异，将为经历痛苦和破坏性更年期症状的妇女提供更好的治疗策略。关于5 -羟色胺治疗反应的信息可能会增加对潮热和5 -羟色胺系统之间联系的理解。