SSRI Study for Functional Dyspepsia (SS)

• Status: Completed
• Trial end date: 2019-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Citalopram; Dexetimide; Serotonin Uptake Inhibitors

Criteria

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