MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

Conditions
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Therapeutic Mechanism of Antidepressants for Refractory FD

Intervention / Treatment
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* Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants
* Other: conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 years old, meeting the criteria for inclusion of refractory FD HP infection negative Right handedness Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: refractory FD patients using antidepressants<br>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. | Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants<br>* On the basis of routine treatment for 8-12 weeks, according to the characteristics of symptoms, a combination of SSRI or SNRI antidepressant drugs was given for 12 weeks.<br>|
| Placebo Comparator: refractory FD patienTS using conventional treatment<br>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. | Other: conventional therapy<br>* Anti-HP, acid suppression, gastrointestinal motility regulation, etc.<br>|
| No Intervention: normal control<br>Age, sex and education matched, right-handed 30 normal people. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nepean Dyspepsia Index | Evaluation of digestive tract symptoms | Change from Baseline at 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zung Self-Rating Anxiety Scale | 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. | Change from Baseline at 12th week | 
| Zung Self-Rating Depression Scale | 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. | Change from Baseline at 12th week | 
| The Pittsburgh Sleep Quality Index | Assessment of Sleep Status | Change from Baseline at 12th week | 
| quality of life survey questionnaire | Assessment of quality of life | Change from Baseline at 12th week | 
| Incidence of Treatment-Emergent Adverse Events | Record any adverse events during treatment | through study completion, an average of 3 years | 
| Functional magnetic resonance imaging | assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres | baseline and 12th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antidepressants, refractory functional dyspepsia, resting fMRI