Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

SSRI Study for Functional Dyspepsia (SS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02153567
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong

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


Condition or disease Intervention/treatment Phase
Dyspepsia Anxiety Depression Drug: Escitalopram Other: Placebo Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Indigestion

Arm Intervention/treatment
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.

Other: Placebo
Placebo will be given for the next 10 weeks.

Experimental: Escitalopram
Escitalopram 5mg & 10mg daily
Drug: Escitalopram
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Justin C.Y. Wu, MBChB(CUHK) Chinese University of Hong Kong

Additional Information:
Layout table for additonal information
Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02153567     History of Changes
Other Study ID Numbers: SS
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Functional dyspepsia
symptom response
postprandial fullness
Anxiety
Depression

Additional relevant MeSH terms:
Layout table for MeSH terms
Citalopram
Serotonin Uptake Inhibitors
Dexetimide
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Depression
Dyspepsia
Behavioral Symptoms
Signs and Symptoms, Digestive
Signs and Symptoms
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents