PHARMACOTHERAPY FOR MINOR DEPRESSION

描述（由申请人提供）：这是一个重新提交的三个网站， 一项为期四年的研究，以评估圣约翰草（SJW）的疗效，标准化 贯叶金丝桃素含量和西酞普兰，与安慰剂相比， 轻度抑郁症（MinorD）。该提案与第一次提交的提案不同， 从正在进行的SJW治疗重度抑郁症的研究中，它：专注于未成年人 仅;包括使用标准化为贯叶金丝桃素的SJW， 制定;有一套完善的主要和次要目标;使用连续的 疗效指标作为研究的主要结局;使用随机回归 用于数据分析的模型;并包括针对无应答者的交叉阶段。 MinorD有很大的影响。MinorD患者经历了大量 发病率，痛苦和功能障碍;即便如此，不到10%的患者 未成年人接受正式治疗。许多人选择与SJW一起自我反省， 未经过测试的治疗MinorD，每年销售额超过2亿美元。 我们建议将300例受试者随机分配至SJW的双盲灵活剂量组， 至1800 mg/天，或西酞普兰至60 mg/天，或安慰剂，持续12周。在12 周，无应答者将被交叉至之前的活性治疗组 未分配;应答者将继续服用研究药物12 周将使用严格的标准来评估症状的改善， 功能障碍和健康改善。这项研究的结果将有 深刻的公共卫生影响，通过提高我们的理解， SJW和标准抗抑郁药治疗MinorD的疗效。

DESCRIPTION (provided by applicant): This is a resubmission of a three-site, four-year study to assess the efficacy of St. John's Wort (SJW), standardized to hyperforin content, and citalopram, compared to placebo for the treatment of Minor Depression (MinorD). The proposal differs from the first submission and from ongoing studies of SJW for major depression, in that it: focuses in MinorD only; includes the use of SJW standardized to hyperforin, a more potent formulation; has a refined set of primary and secondary aims; uses a continuous measure of efficacy as the primary outcome of the study; uses random regression models for data analysis; and includes a cross-over phase for non-responders. MinorD has major effects. Patients with MinorD experience substantial morbidity, distress, and dysfunction; even so, less than 10 percent of patients with MinorD receive formal treatment. Many choose to self-medicate with SJW, an untested treatment for MinorD that generates over $200 million a year in sales. We propose to randomize 300 subjects to double-blind flexible doses of SJW up to 1800 mg/day, or citalopram up to 60 mg/day, or placebo, for 12 weeks. At 12 weeks, nonresponders will be crossed-over to active treatment arms previously unassigned; responders will continue to take study medication for another 12 weeks. Stringent criteria will be used to assess improvement in symptoms, dysfunction, and improvement in well-being. The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD.