Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
研究概览
简要总结
The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
2-week group
Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.
干预措施: Deanxit (Drug)
4-week group
Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).
干预措施: Deanxit (Drug)
结局指标
主要结局
Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Antidepressants discontinuation syndrome was recorded.(1 week)
研究者
Shengliang Chen
professor, chief physician
RenJi Hospital