MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

Therapeutic Mechanism of Antidepressants for Refractory FD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03973567
• Other study ID #: 2016-042
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yiping Chen, PHD
• Phone: 667117
• Email: rosechenaz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Therapeutic Mechanism of Antidepressants for Refractory FD

Intervention

Drug:
• selective 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.

Other:
• conventional therapy
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nepean Dyspepsia Index	Evaluation of digestive tract symptoms	Change from Baseline at 12th week
Secondary	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
Secondary	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
Secondary	The Pittsburgh Sleep Quality Index	Assessment of Sleep Status	Change from Baseline at 12th week
Secondary	quality of life survey questionnaire	Assessment of quality of life	Change from Baseline at 12th week
Secondary	Incidence of Treatment-Emergent Adverse Events	Record any adverse events during treatment	through study completion, an average of 3 years
Secondary	Functional magnetic resonance imaging	assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres	baseline and 12th week