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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flupentixol-Melitracen(psychological and GI) + Omeprazole | Active Comparator | 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. |
|
| Flupentixol-Melitracen(psychological) + Omeprazole | Active Comparator | 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. |
|
| Flupentixol-Melitracen(without explanation) + Omeprazole | Active Comparator | 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. |
|
| proton pump inhibitor | Active Comparator | Prescribe Omeprazole. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Reaction | Number of participants with adverse reactions were recorded to analyze the safety profile of treatment. | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shengliang Chen | RenJi Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25914475 | Derived | Yan XJ, Li WT, Chen X, Wang EM, Liu Q, Qiu HY, Cao ZJ, Chen SL. Effect of clinician-patient communication on compliance with flupentixol-melitracen in functional dyspepsia patients. World J Gastroenterol. 2015 Apr 21;21(15):4652-9. doi: 10.3748/wjg.v21.i15.4652. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deanxit(Psychological and GI) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Flupentixol-Melitracen(psychological and GI) + Omeprazole | Drug | 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. |
|
|
| Flupentixol-Melitracen(psychological) + Omeprazole | Drug | 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. |
|
|
| Flupentixol-Melitracen(without explanation) + Omeprazole | Drug | 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. |
|
|
| 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 |
| FG001 |
| Deanxit(Psychological) + Omeprazole |
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).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. |
| FG002 | Deanxit(Without Explanation) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| FG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deanxit(Psychological and GI) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).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. |
| BG001 | Deanxit(Psychological) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| BG002 | Deanxit(Without Explanation) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| BG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | weeks 1, 2, 4, 8 |
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| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Full Range | units on LDQ scale | week 0 and 8 |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Full Range | units on HADS score | week 0 and 8 |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Adverse Reaction | Number of participants with adverse reactions were recorded to analyze the safety profile of treatment. | Posted | Number | participants | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deanxit(Psychological and GI) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. | 0 | 65 | 6 | 65 | ||
| EG001 | Deanxit(Psychological) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. | 0 | 66 | 9 | 66 | ||
| EG002 | Deanxit(Without Explanation) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. | 0 | 65 | 5 | 65 | ||
| EG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). | 0 | 66 | 2 | 66 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dry mouth | General disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Skin rash | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Liang Chen, MD | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China | 86-21-58752345 | slchenmd@hotmail.com |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D010349 | Patient Compliance |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D005475 | Flupenthixol |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013892 | Thioxanthenes |
| D010879 | Piperazines |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| Male |
|
| OG002 | Deanxit(Without Explanation) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| OG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
|
|
| OG002 | Deanxit(Without Explanation) + Omeprazole | Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). 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. |
| OG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
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| OG003 | Proton Pump Inhibitor | Prescribe Omeprazole. Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). |
|
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