Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by RenJi Hospital
Sponsor:
Information provided by (Responsible Party):
Shengliang Chen, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01851863
First received: May 4, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

The study hypothesis is informing patients that they are given the antidepressant drug because of their dyspepsia symptoms when prescribing would receive best compliance to the antidepressant drug.


Condition Intervention Phase
Dyspepsia
Compliance
Depression
Drug: Omeprazole
Drug: Flupentixol and Melitracen Tablets(for dyspepsia symptoms) + Omeprazole
Drug: Flupentixol and Melitracen Tablets(for depression symptoms) + Omeprazole
Drug: Flupentixol and Melitracen Tablets(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 antidepressant medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    At each visit (weeks 1, 2, 4, 8, and 12), the patient bring back the drug bottle, then the physician recorded the number of pills remaining in the bottle. Patients were categorized as compliant if they returned less than 20%. Pills remained more than 20% or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.


Secondary Outcome Measures:
  • dyspepsia symptom questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Dyspepsia symptoms were evaluated with a self-recorded questionnaire at baseline and each visit. The symptom questionnaire consisted of 8 questions related to upper gastrointestinal tract symptoms: belching, bloating, early satiety, epigastric pain, burning, nausea, postprandial fullness and vomiting . They were rated according to 4 grades: 0 = absent, 1 = mild (do not affect work or life), 2 = middle (affect work and life) and 3 = severe (cannot endure). The symptom scores were calculated as severity grade × frequency per week.

  • psychiatric symptom on Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at baseline and each visit.

  • quality of life rating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The 36-item Short-Form Health Survey Questionnaire was completed for rating health-related quality of life by each patient at baseline and at each visit.

  • adverse reaction [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The adverse reactions were recorded to analyze the safety profile of treatment.


Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Deanxit(for dyspepsia symptoms) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). Tell the patients that they took Deanxit because of their dyspepsia symptoms and study has shown that Deanxit are effective to functional dyspepsia patients.
Drug: Flupentixol and Melitracen Tablets(for dyspepsia symptoms) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). Tell the patients that they took Deanxit because of their dyspepsia symptoms and study has shown that Deanxit are effective to functional dyspepsia patients.
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: Deanxit(for depression symptoms) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). Tell the patients that they took Deanxit because of their depressant symptoms.
Drug: Flupentixol and Melitracen Tablets(for depression symptoms) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). Tell the patients that they took Deanxit because of their depressant symptoms.
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: Deanxit(without explanation) + Omeprazole
Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). Don't inform the patients the reason we prescribe Deanxit.
Drug: Flupentixol and Melitracen Tablets(without explanation) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). Don't inform the patients the reason of prescribing Deanxit.
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 prescribing behaviors 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:

  • functional dyspepsia ROME III criteria
  • All patients were seen by a psychiatrist for a structured psychiatric interview

Exclusion Criteria:

  • received antidepressant or antianxiety drug within 3 months
  • have organic or other functional disease
  • pregnant or breast-feeding
  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

Contacts
Contact: Xiujuan Yan joyceyan0532@126.com

Locations
China
Renji Hospital Recruiting
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
Last Updated: May 13, 2013
Health Authority: China: Ethics Committee

Keywords provided by RenJi Hospital:
functional dyspepsia
depression
compliance

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

ClinicalTrials.gov processed this record on July 20, 2014