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: 7923832
• 负责人: ELLEN W FREEMAN
• 金额: $ 31.19万
• 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/7923832
• 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）：本申请提出了一项科学家网络中的临床试验，他们对更年期过渡非常了解并在进行妇女健康试验中经历了经验，以实现此RFA的主要目标，这是为了加速有效补救措施以减轻血管运动症状。该应用程序与标题为“更年期症状计划 - 找到汗水和潮热的持久答案”（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. Anderson领导，他们曾担任妇女健康，倡议，临床协调中心（西雅图）的联合主管研究者已有十多年了。 MSI-Flash网络在波士顿（L. Cohen和H. Jaffe，PIS），印第安纳波利斯（J Carpenter，PI），加利福尼亚州奥克兰（B Sternfeld和B Caan，PIS，PIS），Philadelphia（E.Freeman，PI）和Seattle（KNEWTON和SETTLE（KNEWTON and SECIS）。这个多学科研究者小组提出了5项随机对照试验，该试验测试了对绝经的一系列行为，思维，荷尔蒙和药理学干预措施。该现场地点提出了一项随机的，安慰剂对照试验，以确定血清素能再摄取抑制剂（SSRI）的功效，以减少与更年期相关的热闪光，并确定已知的热闪光灯在治疗反应中的效果。具体目的是对1）确定SSRI依他普兰的疗效，而安慰剂在降低了热闪光的频率，严重程度和麻烦方面； 2）确定焦虑症，情绪低落，睡眠不良，感知压力，绝经阶段和种族的基线测量的关联，并改善潮热； 3）确定治疗过程中焦虑和情绪抑郁的变化是否与安慰剂相比，依他普兰的炎热闪光降低有关； 4）与安慰剂相比，确定依他普兰的热闪光的时间过程。大约有180名妇女将被随机分配给双盲治疗，并将分层以获得相等数量的非裔美国人和白人妇女。预计网络的其他3个现场也将执行此协议，提供协作和多学科的方法，不同的人群以及快速完成治疗方案。有关治疗疗效和与治疗反应相关的因素（包括对治疗反应的种族差异）的增加信息，将为经历苦恼和破坏性绝经症状的妇女提供更好的治疗策略。有关对血清素能治疗的反应的信息可能会增加对潮热与血清素能系统之间关联的了解。