PHARMACOTHERAPY FOR MINOR DEPRESSION

描述（由申请人提供）：这是三站点的重新提交， 为期四年的研究，旨在评估圣约翰草 (SJW) 的功效，标准化 与安慰剂相比，金丝桃素含量和西酞普兰治疗 轻微抑郁症（MinorD）。该提案与第一次提交的提案不同 正在进行的 SJW 治疗重度抑郁症的研究表明，它： 专注于 MinorD 仅；包括使用 SJW 标准化金丝桃素，这是一种更有效的 配方；有一套完善的主要和次要目标；使用连续的 将疗效衡量作为研究的主要结果；使用随机回归 数据分析模型；并包括无反应者的交叉阶段。 MinorD 有重大影响。 MinorD 患者经历了实质性的 发病、痛苦和功能障碍；即便如此，只有不到 10% 的患者 与MinorD一起接受正规治疗。许多人选择使用 SJW 进行自我治疗，这是一种 MinorD 的未经测试的治疗方法每年产生超过 2 亿美元的销售额。 我们建议对 300 名受试者进行双盲灵活剂量 SJW 的随机分组 至 1800 毫克/天，或西酞普兰至 60 毫克/天，或安慰剂，持续 12 周。 12 点 几周后，无反应者将被交叉到先前的积极治疗组 未分配；应答者将继续服用另外 12 名研究药物 几周。将使用严格的标准来评估症状的改善， 功能障碍，改善健康状况。这项研究的结果将有 通过提高我们对公共卫生的理解，产生深远的公共卫生影响 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.