Depression Clinical Trial
Official title:
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors
Verified date | November 2014 |
Source | RenJi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 262 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Adverse Reaction | Number of participants with adverse reactions were recorded to analyze the safety profile of treatment. | 8 weeks | Yes |
Primary | 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. | weeks 1, 2, 4, 8 | No |
Secondary | 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. | week 0 and 8 | No |
Secondary | 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. | week 0 and 8 | No |
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