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: 8135398
• 负责人: ELLEN W FREEMAN
• 金额: $ 29.98万
• 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/8135398
• 关键词: Address; Adverse effects; African American; Anxiety; Behavioral; Boston; Clinical; Clinical Trials; Coronary heart disease; Data Coordinating Center; Dementia; Depressed mood; Devices; 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; Menopause; Mental Depression; Monitor; Moods; Night Sweating; Patients; Perimenopause; Pharmaceutical Preparations; Philadelphia; Placebos; Population Heterogeneity; Postmenopause; Principal Investigator; Progestins; Protocols documentation; Public Health; Quality of life; Race; Randomized; Randomized Controlled Trials; Reporting; Research Personnel; Risk; Role; Safety; Scientist; Selective Serotonin Reuptake Inhibitor; Serotonin; Serotonin Agents; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Staging; Stress; Stroke; Sweat; Sweating; Symptoms; System; Testing; Therapeutic; Time; Treatment Efficacy; Treatment Protocols; Vasomotor; Woman; Women' s Health; Work; alternative treatment; 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; treatment response

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）：本申请提出在科学家网络中进行临床试验，这些科学家对绝经过渡期有很高的了解，并在进行女性健康试验方面有丰富的经验，以实现本RFA的主要目标，即加速确定缓解血管痉挛症状的有效补救措施。本申请与题为“月经症状倡议-寻找持久的答案出汗和潮热”（MSI-FLASH）的网络一起提交。该网络的数据协调中心（DCC）由A。LaCroix和G.安德森，谁担任联合首席研究员的妇女健康，倡议，临床协调中心（西雅图）超过十年。MSI-FLASH网络在波士顿（L。Cohen和H.贾菲，PI），印第安纳波利斯（J卡彭特，PI），奥克兰，加利福尼亚州（B斯特恩菲尔德和B凯恩，PI），费城（E。弗里曼，PI）和西雅图（K牛顿和S里德，PI）。这个多学科研究小组提出了5项随机对照试验，测试了一系列行为，身心，激素和药物干预更年期潮热。该现场网站提出了一项随机、安慰剂对照试验，以确定β-肾上腺素能再摄取抑制剂（SSRI）减少更年期相关潮热的疗效，并确定潮热的已知协变量对治疗反应的影响。具体目的是：1）确定SSRI艾司西酞普兰与安慰剂相比在减少潮热的频率、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、绝经阶段和种族的基线测量与潮热改善的相关性; 3）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与安慰剂相比减少潮热有关; 4）确定艾司西酞普兰与安慰剂相比改善潮热的时间过程。约180名女性将随机接受双盲治疗，并对入组进行分层，以获得相同数量的非裔美国人和白色女性。预计该网络的其他3个外地地点也将执行这一方案，提供一种协作和多学科的办法，使人口多样化，并迅速完成治疗方案。增加关于治疗疗效和与治疗反应相关的因素的信息，包括治疗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女性提供更好的治疗策略。关于对肾上腺素能治疗的反应的信息可以增加对潮热和肾上腺素能系统之间的关联的理解。