Antidepressant Discontinuation Syndrome, Antidepressant Drug Adverse Reaction, Dyspepsia, Functional Gastrointestinal Disorders
Conditions
Brief summary
The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
Detailed description
Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events. Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.
Interventions
DRUGDeanxit
Central neuromodulators was applied in refractory FD patients for different time
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18-70 years old; * education level higher than middle school; * met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months; * absence of Helicobacter pylori infection; * signed written informed consent for participation in the study.
Exclusion criteria
* evidence of organic digestive diseases; * diabetes, cancer and other diseases might affect GI function; * pregnancy, lactation or breastfeeding; * a history of allergic reaction to any of the drugs used in the study; * participation in other clinical trials in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes. | 2 weeks and 4 weeks | The LDQ scores of 0-4 were classified as very mild dyspepsia, 5-8 as mild dyspepsia, 9-15 as moderate dyspepsia, and \>15 as severe or very severe dyspepsia. |
| Changes from baseline Patient Health Questionaire-9 (PHQ-9) scores at 2 weeks and 4 weeks was obtained to assess the depression contition after treatment. | 2 weeks and 4 weeks | The PHQ-9 scores of 0-4 were classified as none or minimal depression, 5-9 as mild, 10-14 as moderate, 15-19 as moderately severe, and ≥20 as severe depression. |
| Changes from baseline Generalized Anxiety Questonaire-7 (GAD-7) scores at 2 weeks and 4 weeks were obtained to assess the anxiety contition after treatment. | 2 weeks and 4 weeks | The GAD-7 scores of 0-4 were classified as the absence of anxiety, 5-9 as mild, 10-14 as moderate, and ≥15 as severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressants discontinuation syndrome was recorded. | 1 week | Rate of patients with dicscontinuation symdrome including headache, insomia, or flu-like reactions was obtained after antidepressant withdrawal within 1 week. |
Countries
China
Contacts
Primary ContactShengliang Chen, PhD
Outcome results
None listed