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SSRI Study for Functional Dyspepsia (SS)

Chinese University of Hong Kong · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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anxietydepression
Background: Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia (FD) is uncertain. Clinical experience and community studies show that FD is strongly associated with common mood disorders especially depression and anxiety disorders, which can be treated with serotonin selective uptake receptor (SSRI). Our previous study shows that the relief of FD symptom has an association with the change of plasma serotonin and ghrelin profile. However, the correlation between plasma serotonin level in FD patients treated with SSRI is lacking in these studies. Indication: Functional dyspepsia patients Study center(s): Prince of Wales Hospital, Hong Kong Aims : * To evaluate the effect of SSRI treatment on change of plasma serotonin level * To evaluate the relationship between dyspeptic symptom and change of plasma serotonin level Study medication: Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus Placebo for 10 weeks Study design: Double-blind randomized placebo-controlled trial Number of subjects:72 \- 36 patients (18 male and 18 female) and 36 age-and-sex-matched healthy controls Patient population: Functional dyspepsia patients age 18-60, with element of anxiety or depression Duration of study: 1 June 2013 - 30 November 2015 Primary variable(s): Change of serotonin and ghrelin level in blood plasma after medication treatment Secondary variable(s): Rate of adequate relief using global symptom assessment and symptom scores Number of visits: 2
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