Clinical trial NCT01851863: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Compliance
Depression
Keywords: functional dyspepsia
depression
compliance
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compliance of Flupentixol-Melitracen
timeFrame: weeks 1, 2, 4, 8
Secondary outcomes:
measure: Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8
timeFrame: week 0 and 8
measure: Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
timeFrame: week 0 and 8
Other outcomes:
measure: Number of Participants With Adverse Reaction
timeFrame: 8 weeks
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: RenJi Hospital
name: Shengliang Chen
role: STUDY_DIRECTOR
References:
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.