Phase 4
Completed N=262
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Dyspepsia · Compliance · Depression
Source: ClinicalTrials.gov NCT01851863 ↗
Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Compliance of Flupentixol-Melitracen — 44; 28; 31 participants
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' effects might improve compliance with psychoactive agent regimens among FD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance of Flupentixol-Melitracen |
44; 28; 31 | — |
| SECONDARY Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 |
-3.85; -2.51; -2.49; -1.31 | — |
| SECONDARY Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 |
-4.46; -2.29; -2.78; -1.68; -4.82; -2.25 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01851863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.