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