At a glance
ClinicalIndex Comparison Record- ✓Normal esophagogastroduodenoscopy (EGD) within the past 5 years without esophagitis, Barrett's esophagus, cancer, erosions, or ulcer disease
- ✓Confirmed diagnosis of functional dyspepsia
- ✓May have failed to adequately respond to antisecretory therapy (first-line therapy for FD); adequate response suggests underlying GERD and unsuitability for this trial
- ✕Any documented history of endoscopic esophagitis, or predominant heartburn/acid regurgitation, or these symptoms ≥2 times per week in prior year
- ✕Adequate response to antisecretory therapy per physician interview
- ✕Any documented peptic ulcer disease
- ✕Regular use of NSAIDs except low-dose aspirin ≤325 mg/day
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Antidepressant Therapy for Functional Dyspepsia
In Brief
A Phase 3 clinical trial evaluating Amitriptyline, Escitalopram, and 1 other intervention for Dyspepsia and Other Specified Disorders of Function of Stomach. Completed, enrolled 292 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.
Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.