SSRI Study for Functional Dyspepsia (SS)
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|ClinicalTrials.gov Identifier: NCT02153567|
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : January 31, 2019
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.
Functional dyspepsia patients
Prince of Wales Hospital, Hong Kong
- 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
Escitalopram (Lexapro) 5mg daily for first 2 weeks, and then 10 mg daily for 8 weeks versus Placebo for 10 weeks
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
Functional dyspepsia patients age 18-60, with element of anxiety or depression
Duration of study: 1 June 2013 - 30 November 2015
Change of serotonin and ghrelin level in blood plasma after medication treatment
Rate of adequate relief using global symptom assessment and symptom scores
Number of visits: 2
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia Anxiety Depression||Drug: Escitalopram Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Selective Serotonin Reuptake Inhibitor on Satiety Function in Patients With Functional Dyspepsia|
|Actual Study Start Date :||December 6, 2013|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||January 9, 2019|
Placebo Comparator: Control (Placebo) group
Identical looking placebo (once daily)
Double blinding of study medication is achieved by repacking Escitalopram 5mg and 10mg as blue and green capsules respectively.. Identical appearing placebos packed in blue and green capsules will be used for the control group.
Placebo will be given for the next 10 weeks.
Escitalopram 5mg & 10mg daily
Escitalopram 5mg daily will be given for the first 2 weeks and then Escitalopram 10mg daily will be given for the next 8 weeks.
Other Name: Lexapro
- To evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment [ Time Frame: Week 8 ]evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment
- To measure expression of serotonin and ghrelin blood plasma using global symptom assessment, symptom scores and the fullness rating of the Fullness Rating Scale (FRS) during satiety test [ Time Frame: At 28 minute on satiety test ]measure expression of serotonin and ghrelin blood plasma using global symptom
- To measure the rate of adequate relief using global symptom assessment, symptom scores and the fullness rating of the Fullness Rating Scale (FRS) during satiety test [ Time Frame: During 28 minute of satiety test ]measure the rate of adequate relief using global symptom assessment, symptom scores and the fullness rating of the Fullness Rating Scale (FRS) during satiety test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153567
|Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Justin C.Y. Wu, MBChB(CUHK)||Chinese University of Hong Kong|