Status:
COMPLETED
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Lead Sponsor:
RenJi Hospital
Conditions:
Dyspepsia
Compliance
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of FD symptoms and the drugs' ...
Detailed Description
Antidepressive agents have been proved to be effective in the treatment of functional dyspepsia (FD) patients. However, one of the factors that limit therapeutic benefit is the poor compliance with pr...
Eligibility Criteria
Inclusion
- met the ROME III criteria for FD;
- education level no lower than high school;
- Hospital Anxiety and Depression Scale (HADS) score \> 8 respectively;
- absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
- absence of H. pylori infection
Exclusion
- known allergy to omeprazole, flupenthixol or melitracen;
- any evidence of organic digestive diseases;
- reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms;
- severe psychological symptoms that affected life and work;
- pregnancy or breastfeeding;
- recent myocardial infarction or cardiac arrhythmias;
- previous gastric surgery;
- use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT01851863
Start Date
May 1 2013
End Date
June 1 2014
Last Update
February 23 2015
Active Locations (1)
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1
Renji Hospital
Shanghai, China