Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors

Conditions
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Dyspepsia, Compliance, Depression

Intervention / Treatment
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* Drug: Omeprazole
* Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole
* Drug: Flupentixol-Melitracen(psychological) + Omeprazole
* Drug: Flupentixol-Melitracen(without explanation) + Omeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flupentixol-Melitracen(psychological and GI) + Omeprazole<br>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. | Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole<br>* 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.<br>* Other names: Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China);|
| Active Comparator: Flupentixol-Melitracen(psychological) + Omeprazole<br>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. | Drug: Flupentixol-Melitracen(psychological) + Omeprazole<br>* 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.<br>* Other names: Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China);|
| Active Comparator: Flupentixol-Melitracen(without explanation) + Omeprazole<br>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. | Drug: Flupentixol-Melitracen(without explanation) + Omeprazole<br>* 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.<br>* Other names: Omeprazole brand name: Aoke (produced by Changzhou Siyao Pharm, China);|
| Active Comparator: proton pump inhibitor<br>Prescribe Omeprazole. | Drug: Omeprazole<br>* Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).<br>* Other names: Brand name: Aoke (produced by Changzhou Siyao Pharm, China);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of Flupentixol-Melitracen | The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance. | weeks 1, 2, 4, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | The severity of patients' dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome. | week 0 and 8 | 
| Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome. | week 0 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, depression, compliance