SSRI Study for Functional Dyspepsia (SS)

NCT02153567 | Completed Phase 3

• 1 other identifier: SS
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dyspepsia; Anxiety; Depression

Keywords

Functional dyspepsia; symptom response; postprandial fullness; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• To evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment

  evaluate the change of serotonin and ghrelin level in blood plasma before and after treatment

  Week 8

Secondary Outcomes (2)

• 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

  At 28 minute on satiety test

• 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

  During 28 minute of satiety test

Study Arms (2)

Control (Placebo) group

PLACEBO COMPARATOR

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.

Other: Placebo

Escitalopram

EXPERIMENTAL

Escitalopram 5mg \& 10mg daily

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram 5mg daily will be given for the first 2 weeks and then Escitalopram 10mg daily will be given for the next 8 weeks.

Also known as: Lexapro

Escitalopram

Placebo OTHER

Placebo will be given for the next 10 weeks.

Control (Placebo) group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Links

• The Chinese University of Hong Kong

MeSH Terms

Conditions

Dyspepsia; Anxiety Disorders; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Justin C.Y. Wu, MBChB(CUHK)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: December 6, 2013
• Primary Completion: December 31, 2018
• Study Completion: January 9, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)