Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, United States.
Contemp Clin Trials. 2012 May;33(3):523-33. doi: 10.1016/j.cct.2012.02.002. Epub 2012 Feb 10.
Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment.
The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD.
The FDTT is an international multicenter, parallel group, randomized, double-blind, placebo-controlled trial to evaluate whether 12 weeks of treatment with escitalopram or amitriptyline improves FD symptoms compared to treatment with placebo. Secondly, it is hypothesized that acceleration of solid gastric emptying, reduction of postprandial satiation, and enhanced gastric volume change with a meal will be significant positive predictors of short- and long-term outcomes for those on antidepressants vs. placebo. The third aim is to examine whether polymorphisms of GNβ3 and serotonin reuptake transporter influence treatment outcomes in FD patients receiving a tricyclic antidepressant, selective serotonin reuptake inhibitor therapy, or placebo.
The FDTT enrollment began in 2006 and is scheduled to randomize 400 patients by the end of 2012 to receive an antidepressant or placebo for 12 weeks, with a 6-month post-treatment follow-up. The study incorporates multiple validated questionnaires, physiological testing, and specific genetic evaluations. The protocol was approved by participating centers' Institutional Review Boards and an independent Data Safety Monitoring Board was established for monitoring to ensure patient safety and a single interim review of the data in December 2010 (ClinicalTrials.gov number NCT00248651).
功能性消化不良（FD）是一种常见的疾病，影响多达 10-25%的个体。FD 会导致大量的医疗费用，并影响生活质量，但目前尚无明确的治疗方法。
功能性消化不良治疗试验（FDTT）旨在测试抗抑郁药（阿米替林或艾司西酞普兰）治疗是否能改善中重度 FD 患者的症状。
FDTT 是一项国际多中心、平行组、随机、双盲、安慰剂对照试验，旨在评估 12 周的艾司西酞普兰或阿米替林治疗与安慰剂治疗相比是否能改善 FD 症状。其次，假设固体胃排空加速、餐后饱腹感减少和餐时胃容量增加将是抗抑郁药与安慰剂相比短期和长期疗效的显著正预测指标。第三个目的是研究在接受三环类抗抑郁药、选择性 5-羟色胺再摄取抑制剂治疗或安慰剂治疗的 FD 患者中，GNβ3 和 5-羟色胺再摄取转运体的多态性是否会影响治疗结果。
FDTT 的招募工作于 2006 年开始，计划在 2012 年底前随机招募 400 名患者，接受抗抑郁药或安慰剂治疗 12 周，并在治疗后进行 6 个月的随访。该研究采用了多种经过验证的问卷、生理测试和特定的遗传评估。该方案已获得参与中心机构审查委员会的批准，并成立了一个独立的数据安全监测委员会，负责监测以确保患者的安全，并在 2010 年 12 月进行了一次数据中期审查（ClinicalTrials.gov 编号：NCT00248651）。
