TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

经前综合症患者的治疗评估

• 批准号: 2872809
• 负责人: ELLEN W FREEMAN
• 金额: $ 29.19万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-02-01 至 2002-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2872809
• 关键词: GABA receptor; alprazolam; antidepressants; clinical research; desipramine; dosage; drug adverse effect; female; hormone therapy; human subject; human therapy evaluation; longitudinal human study; menstrual cycle; neuroendocrine system; premenstrual syndrome; progesterone; quality of life; receptor binding; reproductive system disorder chemotherapy; serotonin inhibitor; sertraline; young adult human (21-34)

DESCRIPTION: Premenstrual syndrome (PMS) is a complex, chronic, menstrually-related disorder, which is reported at severe levels that impairs functioning by 5-10 percent of reproductive-age women. Severe PMS is associated with diminished productivity, lost work time in the prime years of life, and troubled interpersonal relationships, particularly with the partner and children. Only in recent years, and resulting from these studies and other research, has there been scientific information on the efficacy and safety of treatments and investigation of the etiology of PMS. The investigators conceptualize PMS as mood and behavioral changes that derive from central effects, possibly an altered central nervous system (CNS) sensitivity involving changes of gonadal-adrenal steroids. Building on findings of serotonergic involvement in PMS symptoms, the investigators propose to complete and extend studies of the efficacy and safety of serotonergic antidepressant treatment for PMS. The aims of this competing renewal application are to: 1) complete a large clinical study comparing the efficacy of a serotonergic and a noradrenergic antidepressant with a sample size sufficient for definitive results; 2) conduct a randomized, double-blind, placebo-controlled study of intermittent dosing with sertraline administered in the symptomatic premenstrual phase compared to daily dosing; and 3) examine the impact of PMS on functioning, productivity, health care utilization and quality of life before and after medical treatment in aim #1.

描述：经前综合征(PMS)是一种复杂、慢性、 月经相关障碍，据报道，严重程度为 5%-10%的育龄妇女功能受损。严重的经前综合症 与工作效率下降，在黄金时期失去工作时间有关 多年的生活，以及麻烦的人际关系，特别是与 伴侣和孩子。只是在最近几年，由于这些 研究和其他研究，是否有关于 经前综合征的疗效、安全性及病因调查。 研究人员将经前综合症概念化为情绪和行为的改变 源于中枢效应，可能是中枢神经系统的改变 (CNS)敏感性涉及性腺-肾上腺类固醇激素的变化。建房 关于经前综合征症状中5-羟色胺能参与的发现，调查人员 建议完成并扩大对阿司匹林有效性和安全性的研究 经前综合征的5-羟色胺能抗抑郁治疗。这场比赛的目的是 续订申请是为了：1)完成一项大型临床研究比较 5-羟色胺能和去甲肾上腺素能抗抑郁药的疗效 样本大小足以得出确定的结果；2)进行随机、 间歇给药的双盲、安慰剂对照研究 在有症状的经前阶段使用舍曲林与 每日服药；以及3)检查经前综合症对功能、生产力、 医疗服务前后的卫生服务利用和生活质量 目标1中的治疗。