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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| refractory FD patients using antidepressants | Experimental | 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. |
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| refractory FD patienTS using conventional treatment | Placebo Comparator | 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. |
|
| normal control | No Intervention | Age, sex and education matched, right-handed 30 normal people. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nepean Dyspepsia Index | Evaluation of digestive tract symptoms | Change from Baseline at 12th week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiping Chen, PHD | Contact | 667117 | rosechenaz@163.com | |
| Rishen Yu, PHD | Contact | 0571-87784817 |
| Name | Affiliation | Role |
|---|---|---|
| Yiping Chen, PHD | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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|
| conventional therapy | Other | Anti-HP, acid suppression, gastrointestinal motility regulation, etc. |
|
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 |
| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| D000068760 | Serotonin and Noradrenaline Reuptake Inhibitors |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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