drugset / Trial / NCT00248651
Functional Dyspepsia Treatment Trial
Phase 2/3
Completed
292 enrolled
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often interfere with school and work, and weight loss may occur due to dietary restrictions. The hypothesis of this study was that antidepressant therapy is more effective than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The study also examined if antidepressant therapy reduces disability and improves quality of life in functional dyspepsia.
Timeline
- Start
- 2006-10
- Primary completion
- 2013-07
- Completion
- 2013-07
Publications
- Herrick LM, Camilleri M, Schleck CD, Zinsmeister AR, Saito YA, Talley NJ. Effects of Amitriptyline and Escitalopram on Sleep and Mood in Patients With Functional Dyspepsia. Clin Gastroenterol Hepatol. 2018 Mar;16(3):401-406.e2. doi: 10.1016/j.cgh.2017.10.021. Epub 2017 Dec 1.
- Talley NJ, Locke GR, Saito YA, Almazar AE, Bouras EP, Howden CW, Lacy BE, DiBaise JK, Prather CM, Abraham BP, El-Serag HB, Moayyedi P, Herrick LM, Szarka LA, Camilleri M, Hamilton FA, Schleck CD, Tilkes KE, Zinsmeister AR. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Gastroenterology. 2015 Aug;149(2):340-9.e2. doi: 10.1053/j.gastro.2015.04.020. Epub 2015 Apr 25.
- Herrick LM, Locke GR 3rd, Schleck CD, Zinsmeister AR, Treder V, Talley NJ. Dyspepsia in the community: value of a community-based mailed survey to identify potential participants for a randomized clinical trial. Scand J Gastroenterol. 2015 Aug;50(8):959-64. doi: 10.3109/00365521.2014.980317. Epub 2015 Mar 11.
- Talley NJ, Locke GR 3rd, 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. Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. Contemp Clin Trials. 2012 May;33(3):523-33. doi: 10.1016/j.cct.2012.02.002. Epub 2012 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amitriptyline | Small molecule | 50 mg | Oral |
| Comparator | Escitalopram | Small molecule | 10 mg | Oral |