Dyspepsia | SSRI Study for Functional Dyspepsia (SS)
Dyspepsia research study
What is the primary objective of this study?
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
Who is eligible to participate?
Inclusion Criteria: - • Patients with functional dyspepsia that fulfill Rome III criteria - Has element of anxiety or depression reported at baseline screened by HADS (either subscale of HADS - HAS or HDS scores 8 or higher) - Age 18-60 - Provision of written consent - No evidence of structural disease (including at upper endoscopy) that is likely to explain the dyspeptic symptoms Exclusion Criteria: - • Diabetes mellitus - Organic brain syndrome - Moderate or severe Depression diagnosed by Structured Clinical Interview for DSM-IV conducted by a psychiatrist or trained research staff - History of psychosis, bipolar disorder or substance abuse/dependence - On psychiatric medication (SSRI, SNRI, tricyclic antidepressants, anxiolytics) - Has suicidal ideation in the past two weeks as screened by PHQ at baseline assessment - Diagnosis of GERD by GERDQ questionnaire (GERDQ score ≥8) included in the FGI Screening Questionnaire (v.3) completed at baseline visit - Concurrent medications that affect GI motility - History of gastric surgery - Organic disease as cause of dyspepsia - H. pylori infection - Use of PPI or NSAID in the past 4 weeks - Pregnancy - Known hypersensitivity to SSRI - Unable to read Chinese or illiterate
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EscitalopramEscitalopram 5mg daily will be given for the first 2 weeks and then Escitalopram 10mg daily will be given for the next 8 weeks.
Other:PlaceboPlacebo will be given for the next 10 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Control (Placebo) groupIdentical 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.
Start Date: December 6, 2013
Completed Date: January 9, 2019
Phase: Phase 3
Primary Outcome: To evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment
Secondary Outcome: 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
Study sponsors, principal investigator, and references
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK)
Lead Sponsor: Chinese University of Hong Kong