Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT02153567
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02153567
Study Brief:
Protocol Section:
NCT02153567