Treating PMS/PMDD--Research versus Clinical Reality

描述（由申请人提供）：中度至重度经前 多达15-20%的妇女受到骚扰。经过多年的治疗研究 值得注意的是，研究人员已经确定了代理人 有效治疗患有这些疾病的妇女。一个吸引人 改善经前期妇女症状的治疗方法 焦虑症（PMDD）是仅在黄体期使用SRI， 月经周期，一种得到几个随机临床试验支持的方法， 审判以这种方式给药既限制了药物暴露， 对周期的症状阶段产生影响，并且通常被 患者鉴于黄体期给药的积极疗效研究， 食品和药物管理局将批准使用这种方式， 治疗中度至重度经前症状，如PMDD。然而， 这是一种治疗方式， 临床试验，以及可能增强积极研究结果的功能 （监测排卵，由警惕的研究人员进行依从性咨询，以及 关于何时开始用药的指导）明显缺失， 常规临床实践。此外，有证据表明， 能够遵守黄体期给药的临床试验 代表临床实践中常见的女性，因此， 黄体期给药的可行性尚不清楚。这是改良过的R-21 PAR-99-118，“精神疾病的初步有效性试验” 本申请的具体目的是：1）评估是否 在初级保健妇产科实践中，患有中度至重度经前综合症的女性将被 愿意并能够坚持有限的精神药物治疗 月经周期的黄体期; 2）确定是否具体 患者特征（患有中度至重度PMS， 符合PMDD与患有PMDD的标准;有另一个共同发生的 精神或一般医学状况，不限于黄体 周期的阶段与没有其他疾病）影响对 间歇性SRI治疗; 3）评价是否采用回顾性量表 与精神病筛查量表结合使用， 中度至重度经前变化的女性; 4）比较和选择 最能显示经前期改善的结局指标 用SRI治疗后的症状;和5）收集治疗时的症状数据 以估计后续研究所需的效应量。

DESCRIPTION (provided by applicant): Moderate to severe premenstrual disturbances afflict up to 15-20% of women. After years of treatment research that was notable for inconsistent findings, researchers have identified agents that effectively treat women suffering from these conditions. An appealing treatment modality for ameliorating symptoms in women with premenstrual dysphoric disorder (PMDD) is the use of SRIs only during the luteal phase of the menstrual cycle, an approach supported by several randomized clinical trials. Medication administered in this way limits both drug exposure and side effects to the symptomatic phase of the cycle and is often preferred by patients. Given positive efficacy studies for luteal-phase dosing, it is likely that the Food and Drug Administration will approve the use of this modality for the treatment of moderate to severe premenstrual conditions such as PMDD. Yet, this is a treatment modality that has only been evaluated in controlled clinical trials, and features that may have enhanced positive study results (monitoring ovulation, compliance counseling by vigilant study staff, and direction regarding when to initiate medication) are noticeably absent in routine clinical practice. Furthermore, evidence suggests that patients in clinical trials who were able to comply with luteal-phase dosing are not representative of women commonly seen in clinical practice, and thus the feasibility of luteal-phase dosing is unclear. This is a revised R-21 application that responds to PAR-99-118, "Pilot Effectiveness Trials for Mental Disorders" The specific alms of this application are to: 1) Evaluate whether women In a primary care ob-gyn practice with moderate to severe PMS will be willing and able to adhere to psychotropic medication treatment that is limited to the luteal phase of the menstrual cycle; 2) Determine whether specific patient characteristics (suffering from moderate to severe PMS that does not meet criteria for PMDD versus suffering PMDD; having another co-occurring psychiatric or general medical condition that is not limited to the luteal phase of the cycle versus not having other disorders) influence response to Intermittent SRI treatment; 3) Evaluate whether a retrospective scale administered in conjunction with a psychiatric screening scale can identify women with moderate to severe premenstrual changes; 4) Compare and select outcome measures that are most able to show improvement in premenstrual symptoms after treatment with an SRI; and 5) Collect symptom data on treatment as usual in order to estimate the effect size required for a subsequent study.