NCT00248651

Functional Dyspepsia Treatment Trial

Antidepressant Therapy for Functional Dyspepsia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aims of this study were to: 1. Determine whether antidepressant therapy is more efficacious than placebo in relief of the symptoms of functional dyspepsia, adjusting for psychological and psychiatric co-morbidity. The investigators also planned to determine if antidepressant therapy reduces disability, improves quality of life and influences clinical response over 6 months after ceasing medication. 2. Determine if gastric emptying (motor dysfunction) and the nutrient drink test (a test that assesses gastric hypersensitivity and/or gastric accommodation) is altered by antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors (SSRI), and whether subgroups with altered physiology are associated with treatment outcome.

Conditions

• Dyspepsia and Other Specified Disorders of Function of Stomach

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2005-11-04
• Last updated: 2014-07-25
• Results posted: 2014-07-25

Locations

8 sites across 2 countries: United States, Canada