PHARMACOTHERAPY FOR MINOR DEPRESSION

轻度抑郁症的药物治疗

• 批准号: 6802098
• 负责人: ANDREW A NIERENBERG
• 金额: $ 17.55万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-17 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6802098
• 关键词: antidepressants; behavioral /social science research tag; chronic disease /disorder; clinical research; clinical trials; depression; drug administration rate /duration; drug screening /evaluation; functional ability; human subject; human therapy evaluation; mental disorder chemotherapy; outcomes research; patient oriented research; placebos; plant extracts; psychopharmacology; quality of life; self medication; sign /symptom; social psychology

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(申请人提供)：这是一个重新提交的三个站点， 评估圣约翰麦芽汁(SJW)疗效的四年研究，标准化 将金丝桃素含量和西酞普兰与安慰剂进行比较，以治疗 轻度抑郁症(MinorD)。这份提案与第一份提案不同， 来自正在进行的SJW治疗重度抑郁症的研究，因为它：专注于MinorD 只有；包括使用标准化的SJW来金丝桃素，一种更有效的 提法；有一套精炼的主要和次要目标；使用连续的 将疗效测量作为研究的主要结果；使用随机回归 用于数据分析的模型；并包括非响应者的交叉阶段。 MinorD有很大的影响。MinorD患者经历了大量的 发病率、痛苦和功能障碍；即便如此，只有不到10%的患者 患有MinorD的患者接受正规治疗。许多人选择用SJW自我治疗， 未经测试的MinorD治疗方法，每年产生超过2亿美元的销售额。 我们建议将300名受试者随机分成双盲灵活剂量的SJW UP组 至1800毫克/天，或西酞普兰至60毫克/天，或安慰剂，为期12周。在12岁时 几周后，无反应者将被转移到积极的治疗武器之前 未分配；应答者将继续服用研究药物另外12 几周。将使用严格的标准来评估症状的改善， 功能障碍和幸福感的改善。这项研究的结果将会有 通过提高我们对 四逆解郁丸与标准抗抑郁药治疗精神分裂症的疗效比较