Pharmacotherapy for Minor Depression

轻度抑郁症的药物治疗

基本信息

批准号：
6798650
负责人：
ROBERT H HOWLAND
金额：
$ 29.7万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-09-17 至 2006-08-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：这是三个站点的重新提交评估圣约翰麦芽汁（SJW）的功效的四年研究，标准化与安慰剂相比，Hyperforin含量和Citalopram 小抑郁症（Minord）。该提案与第一次提交和从对SJW进行严重抑郁症的持续研究，因为仅有的;包括使用标准化为Hyperforin的SJW的使用，更有效配方；具有一组精致的主要和次要目标；使用连续措施作为研究的主要结果；使用随机回归数据分析模型；并包括非反应者的交叉阶段。 Minord具有重大影响。 Minord的患者经验丰富发病率，困扰和功能障碍；即便如此，只有不到10％的患者 Minord接受正式治疗。许多人选择与sjw自我治疗，未经测试的MINORD治疗，每年的销售额超过2亿美元。我们建议将300名受试者随机用双盲柔性剂量的SJW向上至1800毫克/天，或西妥位丙酰胺最高60毫克/天或安慰剂，持续12周。 12岁几周，以前将不反应到主动治疗臂未分配；响应者将继续服用12次学习药物几周。严格的标准将用于评估症状的改善，功能障碍和福祉的改善。这项研究的结果将有通过改善我们对 SJW和标准抗抑郁药对MINORD治疗的功效。