title: Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, United States.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Talley
authors.forename: G Richard
authors.initials: GR
authors.lastname: Locke
authors.forename: Linda M
authors.initials: LM
authors.lastname: Herrick
authors.forename: Vickie M
authors.initials: VM
authors.lastname: Silvernail
authors.forename: Charlene M
authors.initials: CM
authors.lastname: Prather
authors.forename: Brian E
authors.initials: BE
authors.lastname: Lacy
authors.forename: John K
authors.initials: JK
authors.lastname: DiBaise
authors.forename: Colin W
authors.initials: CW
authors.lastname: Howden
authors.forename: Darren M
authors.initials: DM
authors.lastname: Brenner
authors.forename: Ernest P
authors.initials: EP
authors.lastname: Bouras
authors.forename: Hashem B
authors.initials: HB
authors.lastname: El-Serag
authors.forename: Bincy P
authors.initials: BP
authors.lastname: Abraham
authors.forename: Paul
authors.initials: P
authors.lastname: Moayyedi
authors.forename: Alan R
authors.initials: AR
authors.lastname: Zinsmeister
mesh_terms: D000639:Amitriptyline / Q000627:therapeutic use*; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use*; D016001:Confidence Intervals; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D006305:Health Status Indicators; D006801:Humans; D016017:Odds Ratio; D010597:Pharmacogenetics; D010919:Placebos; D011594:Psychometrics; D012107:Research Design; D012307:Risk Factors; D057566:Self Report; D011795:Surveys and Questionnaires
chemical_list: D018687:Antidepressive Agents, Second-Generation; D000929:Antidepressive Agents, Tricyclic; D010919:Placebos; D015283:Citalopram; D000639:Amitriptyline