Therapeutic Mechanism of Antidepressants for Refractory FD
Conditions
Keywords
antidepressants, refractory functional dyspepsia, resting fMRI
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.
Interventions
DRUGselective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants
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.
OTHERconventional therapy
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nepean Dyspepsia Index | Change from Baseline at 12th week | Evaluation of digestive tract symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| quality of life survey questionnaire | Change from Baseline at 12th week | Assessment of quality of life |
Countries
China
Contacts
Primary ContactYiping Chen, PHD
Backup ContactRishen Yu, PHD
Outcome results
None listed