Dyspepsia and Other Specified Disorders of Function of Stomach Clinical Trial
Official title:
Antidepressant Therapy for Functional Dyspepsia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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