Back to resultsCompliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Primary Purpose
Dyspepsia, Compliance, Depression
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Omeprazole
Flupentixol-Melitracen(psychological and GI) + Omeprazole
Flupentixol-Melitracen(psychological) + Omeprazole
Flupentixol-Melitracen(without explanation) + Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring functional dyspepsia, depression, compliance
Eligibility Criteria
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
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Flupentixol-Melitracen(psychological and GI) + Omeprazole
Flupentixol-Melitracen(psychological) + Omeprazole
Flupentixol-Melitracen(without explanation) + Omeprazole
proton pump inhibitor
Arm 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.
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.
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.
Prescribe Omeprazole.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01851863
Brief Title
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
Official Title
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Compliance, Depression
Keywords
functional dyspepsia, depression, compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flupentixol-Melitracen(psychological and GI) + Omeprazole
Arm Type
Active Comparator
Arm 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.
Arm Title
Flupentixol-Melitracen(psychological) + Omeprazole
Arm Type
Active Comparator
Arm 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.
Arm Title
Flupentixol-Melitracen(without explanation) + Omeprazole
Arm Type
Active Comparator
Arm 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.
Arm Title
proton pump inhibitor
Arm Type
Active Comparator
Arm Description
Prescribe Omeprazole.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Brand name: Aoke (produced by Changzhou Siyao Pharm, China)
Intervention Description
Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
Intervention Type
Drug
Intervention Name(s)
Flupentixol-Melitracen(psychological and GI) + Omeprazole
Other Intervention Name(s)
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 Description
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.
Intervention Type
Drug
Intervention Name(s)
Flupentixol-Melitracen(psychological) + Omeprazole
Other Intervention Name(s)
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 Description
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.
Intervention Type
Drug
Intervention Name(s)
Flupentixol-Melitracen(without explanation) + Omeprazole
Other Intervention Name(s)
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 Description
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.
Primary Outcome Measure Information:
Title
Compliance of Flupentixol-Melitracen
Description
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.
Time Frame
weeks 1, 2, 4, 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8
Description
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.
Time Frame
week 0 and 8
Title
Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
Description
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.
Time Frame
week 0 and 8
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Reaction
Description
Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Organizational Affiliation
RenJi Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25914475
Citation
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.
Results Reference
derived
Learn more about this trial
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
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