TREATMENT EVALUATION IN PREMENSTRUAL SYNDROME PATIENTS

经前综合征（PMS）是一种复杂的，慢性的， 据报道，严重程度为 5- 10%的育龄妇女的功能受损。 重度PMS 与生产力下降，黄金时期的工作时间损失有关 多年的生活，和麻烦的人际关系，特别是与 伴侣和孩子。 只是近年来，由于这些 研究和其他研究，是否有关于 治疗的有效性和安全性以及PMS病因学的研究。 研究人员将经前综合征概念化为情绪和行为变化， 源自中枢效应，可能是中枢神经系统改变 (CNS)涉及性腺-肾上腺类固醇变化的敏感性。 建筑 研究人员发现， 建议完成和扩展关于以下药物的疗效和安全性的研究： 经前综合征的多巴胺能抗抑郁药治疗。 这次比赛的目的是 更新申请是：1）完成一项大型临床研究， 肾上腺素能和去甲肾上腺素能抗抑郁药与 样本量足以获得确定的结果; 2）进行随机， 间歇给药的双盲、安慰剂对照研究， 舍曲林在症状性经前期给药， 每日剂量;和3）检查PMS对功能，生产力， 医疗前后卫生服务利用与生活质量 目标#1中的治疗。

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.