Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Dyspepsia; Compliance; Depression

Treatments: Drug: Flupentixol-Melitracen(psychological) + Omeprazole; Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole; Drug: Flupentixol-Melitracen(without explanation) + Omeprazole; Drug: Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01851863

RJYYXHNK-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 262 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

262 participants in 4 patient groups

Flupentixol-Melitracen(psychological and GI) + Omeprazole

Active Comparator group

Description:

The 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.

Treatment:

Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole

Flupentixol-Melitracen(psychological) + Omeprazole

Active Comparator group

Description:

The 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.

Treatment:

Drug: Flupentixol-Melitracen(psychological) + Omeprazole

Flupentixol-Melitracen(without explanation) + Omeprazole

Active Comparator group

Description:

In 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.

Treatment:

Drug: Flupentixol-Melitracen(without explanation) + Omeprazole

proton pump inhibitor

Active Comparator group

Description:

Prescribe Omeprazole.

Treatment:

Drug: Omeprazole