DyspepsiaPhase 4NCT01851863
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia
A Phase 4 study testing Omeprazole, Flupentixol-Melitracen(psychological and GI) + Omeprazole and Flupentixol-Melitracen(psychological) + Omeprazole in people with Dyspepsia and Compliance, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia, Compliance, Depression
- What is being tested?
- Omeprazole, Flupentixol-Melitracen(psychological and GI) + Omeprazole and Flupentixol-Melitracen(psychological) + Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors
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.
Read the 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.
- Conditions
- Dyspepsia, Compliance, Depression
- Being tested
- Omeprazole, Flupentixol-Melitracen(psychological and GI) + Omeprazole, Flupentixol-Melitracen(psychological) + Omeprazole, Flupentixol-Melitracen(without explanation) + Omeprazole
- Keywords
- functional dyspepsia, depression, compliance
- Medical subject headings
- Dyspepsia, Patient Compliance, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Brand name: Aoke (produced by Changzhou Siyao Pharm, China)
Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
Flupentixol-Melitracen(psychological and GI) + OmeprazoleDrug
Also called 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)
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) + OmeprazoleDrug
Also called 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)
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) + OmeprazoleDrug
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole |
| 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. Receives: Drug: Flupentixol-Melitracen(psychological) + Omeprazole |
| 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. Receives: Drug: Flupentixol-Melitracen(without explanation) + Omeprazole |
| proton pump inhibitor | Active comparator | Prescribe Omeprazole. Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weeks 1, 2, 4, 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: week 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
- Investigators
- Shengliang Chen, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851863
- Sponsor's protocol ID
- RJYYXHNK-001
- Status last verified
- Nov 2014
- First submitted
- 4 May 2013
- Last updated
- 23 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25914475
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors
- ClinicalTrials.gov ID
- NCT01851863
- Acronym / sponsor ID
- RJYYXHNK-001
- Conditions
- Dyspepsia, Compliance, Depression
- Keywords
- functional dyspepsia, depression, compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flupentixol-Melitracen(psychological and GI) + Omeprazole | Active comparator | Drug: 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) + Omeprazole | Active comparator | Drug: 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) + Omeprazole | Active comparator | Drug: 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 inhibitor | Active comparator | Drug: OmeprazolePrescribe Omeprazole. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Brand name: Aoke (produced by Changzhou Siyao Pharm, China)Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). | Drug | proton pump inhibitor |
| Flupentixol-Melitracen(psychological and GI) + OmeprazoleAlso: 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)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. | Drug | Flupentixol-Melitracen(psychological and GI) + Omeprazole |
| Flupentixol-Melitracen(psychological) + OmeprazoleAlso: 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)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. | Drug | Flupentixol-Melitracen(psychological) + Omeprazole |
| Flupentixol-Melitracen(without explanation) + OmeprazoleAlso: 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)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. | Drug | Flupentixol-Melitracen(without explanation) + Omeprazole |
Primary outcome
Compliance of Flupentixol-Melitracen
Time frame: weeks 1, 2, 4, 8
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.
2 secondary outcomes
Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8
Time frame: week 0 and 8
Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
Time frame: week 0 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25914475Yan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengliang Chen study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole, Flupentixol-Melitracen(psychological and GI) + Omeprazole and Flupentixol-Melitracen(psychological) + Omeprazole in people with Dyspepsia and Compliance, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of Flupentixol-Melitracen (time frame: weeks 1, 2, 4, 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.