Functional Dyspepsia Treatment Trial (FDTT): A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics

Nicholas J. Talley, G. Richard Locke, Linda M. Herrick, Vickie M. Silvernail, Charlene M. Prather, Brian E. Lacy, John K. DiBaise, Colin W. Howden, Darren M. Brenner, Ernest P. Bouras, Hashem B. El-Serag, Bincy P. Abraham, Paul Moayyedi, Alan R. Zinsmeister

Research output: Contribution to journalArticle

30 Citations (Scopus)

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. Objectives: 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. Design: 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).

Original languageEnglish (US)
Pages (from-to)523-533
Number of pages11
JournalContemporary Clinical Trials
Volume33
Issue number3
DOIs
StatePublished - May 2012

Fingerprint

Dyspepsia
Pharmacogenetics
Psychopathology
Antidepressive Agents
Randomized Controlled Trials
Placebos
Citalopram
Amitriptyline
Therapeutics
Clinical Trials Data Monitoring Committees
Satiation
Serotonin Plasma Membrane Transport Proteins
Tricyclic Antidepressive Agents
Gastric Emptying
Research Ethics Committees
Serotonin Uptake Inhibitors
Genetic Testing
Patient Safety
Health Care Costs
Meals

Keywords

  • Amitriptyline
  • Antidepressive agents
  • Citalopram
  • Clinical trial
  • Dyspepsia
  • National Institute of Diabetes and Digestive and Kidney Diseases

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

Functional Dyspepsia Treatment Trial (FDTT) : A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. / Talley, Nicholas J.; Locke, G. Richard; Herrick, Linda M.; Silvernail, Vickie M.; Prather, Charlene M.; Lacy, Brian E.; DiBaise, John K.; Howden, Colin W.; Brenner, Darren M.; Bouras, Ernest P.; El-Serag, Hashem B.; Abraham, Bincy P.; Moayyedi, Paul; Zinsmeister, Alan R.

In: Contemporary Clinical Trials, Vol. 33, No. 3, 05.2012, p. 523-533.

Research output: Contribution to journalArticle

Talley, NJ, Locke, GR, Herrick, LM, Silvernail, VM, Prather, CM, Lacy, BE, DiBaise, JK, Howden, CW, Brenner, DM, Bouras, EP, El-Serag, HB, Abraham, BP, Moayyedi, P & Zinsmeister, AR 2012, 'Functional Dyspepsia Treatment Trial (FDTT): A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics', Contemporary Clinical Trials, vol. 33, no. 3, pp. 523-533. https://doi.org/10.1016/j.cct.2012.02.002
Talley, Nicholas J. ; Locke, G. Richard ; Herrick, Linda M. ; Silvernail, Vickie M. ; Prather, Charlene M. ; Lacy, Brian E. ; DiBaise, John K. ; Howden, Colin W. ; Brenner, Darren M. ; Bouras, Ernest P. ; El-Serag, Hashem B. ; Abraham, Bincy P. ; Moayyedi, Paul ; Zinsmeister, Alan R. / Functional Dyspepsia Treatment Trial (FDTT) : A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. In: Contemporary Clinical Trials. 2012 ; Vol. 33, No. 3. pp. 523-533.
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