Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Condition: Dyspepsia; Compliance; Depression
MeSH terms: Dyspepsia; Depression
Intervention: Omeprazole; Flupentixol-Melitracen(psychological and GI) + Omeprazole; Flupentixol-Melitracen(psychological) + Omeprazole; Flupentixol-Melitracen(without explanation) + Omeprazole
Intervention description: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).; Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.; Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.; Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 262.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: functional dyspepsia; depression; compliance

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.
    

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