Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Nepean Dyspepsia Index
研究概览
简要总结
In this study, diffusion tensor imaging（DTI）technique was used to evaluate the brain microstructures and connective white matter microstructures in patients with refractory FD, resting fMRI was used to evaluate the functional connectivity between hemispheres, and neuroimaging changes after antidepressant intervention were observed to explore the activation patterns of resting brain homeostasis-receptive network areas in patients with refractory FD. We aimed to explore microstructure of white matter and gray matter and functional connectivity between hemispheres to explain the therapeutic mechanism of antidepressants.
详细描述
In this study, functional magnetic resonance imaging (fMRI) was used to investigate the abnormal activation patterns of brain regions in patients with refractory FD in resting state, and to observe the changes of brain functions after antidepressant treatment, in order to find scientific evidence for exploring the etiology, neuropathological mechanism and the mechanism of antidepressant treatment of refractory FD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years old, meeting the criteria for inclusion of refractory FD
- •HP infection negative
- •Right handedness
排除标准
- •Antidepressant drug allergists
- •History of gastroduodenal surgery;
- •Researchers judged suicidal ideation.
- •Women in pregnancy or lactation.
- •Patients with uncorrected narrow angle glaucoma.
- •There was a history of epileptic seizures.
- •suffering from any serious or unstable medical disease or disease.
- •Addiction to illicit drugs or alcohol and unwillingness to discontinue use during the study period.
- •Patients can't express their complaints correctly and can't cooperate with the researcher.
研究组 & 干预措施
refractory FD patients using antidepressants
Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, proton pump inhibitors (PPI), motivation and anti-Helicobacter pylori（HP） treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.
干预措施: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants (Drug)
refractory FD patienTS using conventional treatment
Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, PPI, motivation and anti-HP treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.
干预措施: conventional therapy (Other)
结局指标
主要结局
Nepean Dyspepsia Index
时间窗: Change from Baseline at 12th week
Evaluation of digestive tract symptoms
次要结局
- quality of life survey questionnaire(Change from Baseline at 12th week)
- Zung Self-Rating Anxiety Scale(Change from Baseline at 12th week)
- Zung Self-Rating Depression Scale(Change from Baseline at 12th week)
- The Pittsburgh Sleep Quality Index(Change from Baseline at 12th week)
- Incidence of Treatment-Emergent Adverse Events(through study completion, an average of 3 years)
- Functional magnetic resonance imaging(baseline and 12th week)