Clinical trial NCT03973567: MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
Official title: Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Therapeutic Mechanism of Antidepressants for Refractory FD
Keywords: antidepressants
refractory functional dyspepsia
resting fMRI
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nepean Dyspepsia Index
timeFrame: Change from Baseline at 12th week
Secondary outcomes:
measure: Zung Self-Rating Anxiety Scale
timeFrame: Change from Baseline at 12th week
measure: Zung Self-Rating Depression Scale
timeFrame: Change from Baseline at 12th week
measure: The Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline at 12th week
measure: quality of life survey questionnaire
timeFrame: Change from Baseline at 12th week
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: through study completion, an average of 3 years
measure: Functional magnetic resonance imaging
timeFrame: baseline and 12th week
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
name: Yiping Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References: