MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
- Conditions
- Therapeutic Mechanism of Antidepressants for Refractory FD
- Interventions
- Registration Number
- NCT03973567
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Age 18-60 years old, meeting the criteria for inclusion of refractory FD
- HP infection negative
- Right handedness
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description refractory FD patients using antidepressants selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) 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. refractory FD patienTS using conventional treatment conventional therapy 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.
- Primary Outcome Measures
Name Time Method Nepean Dyspepsia Index Change from Baseline at 12th week Evaluation of digestive tract symptoms
- Secondary Outcome Measures
Name Time Method quality of life survey questionnaire Change from Baseline at 12th week Assessment of quality of life
Zung Self-Rating Anxiety Scale Change from Baseline at 12th week It is a scale measures anxiety level of patients including 20 items, and total score ranges from 20 to 80. Higher values represent a worse outcome.
Zung Self-Rating Depression Scale Change from Baseline at 12th week It is a scale measures depression level of patients including 20 items, and total score ranges from 20 to 80. Higher values represent a worse outcome.
The Pittsburgh Sleep Quality Index Change from Baseline at 12th week Assessment of Sleep Status
Incidence of Treatment-Emergent Adverse Events through study completion, an average of 3 years Record any adverse events during treatment
Functional magnetic resonance imaging baseline and 12th week assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres
Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China