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Dyspepsia | Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

Dyspepsia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dyspepsia

Compliance

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:OmeprazolePrescribe Omeprazole(20mg, po, qd, 30min before breakfast).

Drug:Flupentixol-Melitracen(psychological and GI) + OmeprazolePrescribe 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.

Drug:Flupentixol-Melitracen(psychological) + OmeprazolePrescribe 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.

Drug:Flupentixol-Melitracen(without explanation) + OmeprazolePrescribe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Flupentixol-Melitracen(psychological and GI) + OmeprazoleThe patients in Group 1 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.

Flupentixol-Melitracen(psychological) + OmeprazoleThe patients in Group 2 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.

Flupentixol-Melitracen(without explanation) + OmeprazoleIn Group 3, 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.

proton pump inhibitorPrescribe Omeprazole.

Study Status

Completed

Start Date: May 2013

Completed Date: June 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Compliance of Flupentixol-Melitracen

Secondary Outcome: Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8

Study sponsors, principal investigator, and references

Principal Investigator: Shengliang Chen

Lead Sponsor: RenJi Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01851863

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