Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shengliang Chen, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01851863
First received: May 4, 2013
Last updated: February 10, 2015
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Dyspepsia
Compliance
Depression
Drug: Omeprazole
Drug: Flupentixol-Melitracen(psychological and GI) + Omeprazole
Drug: Flupentixol-Melitracen(psychological) + Omeprazole
Drug: Flupentixol-Melitracen(without explanation) + Omeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • Compliance of Flupentixol-Melitracen [ Time Frame: weeks 1, 2, 4, 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 0 and 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 0 and 8 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Participants With Adverse Reaction [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.


Enrollment: 262
Study Start Date: May 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flupentixol-Melitracen(psychological and GI) + Omeprazole
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
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.
Other Names:
  • 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)
Active Comparator: Flupentixol-Melitracen(psychological) + Omeprazole
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
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.
Other Names:
  • 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)
Active Comparator: Flupentixol-Melitracen(without explanation) + Omeprazole
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
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.
Other Names:
  • 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)
Active Comparator: proton pump inhibitor
Prescribe Omeprazole.
Drug: Omeprazole
Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
Other Name: Brand name: Aoke (produced by Changzhou Siyao Pharm, China)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851863

Locations
China
Renji Hospital
Shanghai, China
Sponsors and Collaborators
RenJi Hospital
Investigators
Study Director: Shengliang Chen RenJi Hospital
  More Information

No publications provided

Responsible Party: Shengliang Chen, professor,chief physician, RenJi Hospital
ClinicalTrials.gov Identifier: NCT01851863     History of Changes
Other Study ID Numbers: RJYYXHNK-001
Study First Received: May 4, 2013
Results First Received: April 13, 2014
Last Updated: February 10, 2015
Health Authority: China: Ethics Committee

Keywords provided by RenJi Hospital:
functional dyspepsia
depression
compliance

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms
Signs and Symptoms, Digestive
Antidepressive Agents
Flupenthixol
Flupenthixol decanoate
Omeprazole
Anti-Ulcer Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 27, 2015