Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Condition: Dyspepsia; Compliance; Depression
MeSH terms: Dyspepsia; Depression
Study type: Interventional
Phase: Phase 4

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.
    

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 prescribed drugs. The possible reasons for lack of compliance include
      the patient's health beliefs (e.g., that people who took such agents is possibly considered
      insane in China), lack of knowledge about antidepressants (that they are addictive or can be
      stopped on recovery), and aversion to side effects. The investigators propose to examine
      whether different clinician-patient communication methods could affect adherence to
      antidepressant drugs in functional dyspepsia patients.
    

Intervention name(s): Omeprazole; Flupentixol-Melitracen(psychological and GI) + Omeprazole; Flupentixol-Melitracen(psychological) + Omeprazole; Flupentixol-Melitracen(without explanation) + Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Brand name: Aoke (produced by Changzhou Siyao Pharm, China); Flupentixol and Melitracen Tablets brand name: Deanxit(produced by H.Lundbeck A/S, Copenhagen, Denmark ); Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China); Flupentixol and Melitracen Tablets brand name: Deanxit(produced by H.Lundbeck A/S, Copenhagen, Denmark ); Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China); Flupentixol and Melitracen Tablets brand name: Deanxit(produced by H.Lundbeck A/S, Copenhagen, Denmark ); Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China)
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: functional dyspepsia; depression; compliance