Functional Dyspepsia Treatment Trial

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.

Conditions

• Dyspepsia and Other Specified Disorders of Function of Stomach

Interventions

DRUG

Amitriptyline

25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.

DRUG

Escitalopram

10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.

DRUG

Placebo

Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Earnest P Bouras, M.D. · Mayo Clinic

• John K. DiBaise, M.D. · Mayo Clinic

• Colin P Howden, M.D. · Northwestern University Chicago

• Charlene M Prather, M.D. · St. Louis University

• Nicholas J Talley, M.D.,Ph.D. · Mayo Clinic

• Brian E. Lacy, M.D., Ph.D. · Dartmouth-Hitchcock Medical Center

• G. R. Locke, III, M.D. · Mayo Clinic

• Bincy P Abraham, M.D., M.S. · Baylor College of Medicine

• Hashem El-Serag, M.D. · Baylor College of Medicine

• Paul Moayyedi, M.D. · McMaster University Centre, Hamilton, Ontario

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• United States
• Canada

Study Locations