MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

NCT ID: NCT03973567

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-06-01

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.

Conditions

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Therapeutic Mechanism of Antidepressants for Refractory FD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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refractory FD patients using antidepressants

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.

Group Type EXPERIMENTAL

selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants

Intervention Type 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.

refractory FD patienTS using conventional treatment

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.

Group Type PLACEBO_COMPARATOR

conventional therapy

Intervention Type OTHER

Anti-HP, acid suppression, gastrointestinal motility regulation, etc.

normal control

Age, sex and education matched, right-handed 30 normal people.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

conventional therapy

Anti-HP, acid suppression, gastrointestinal motility regulation, etc.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yiping Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiping Chen, PHD

Role: CONTACT

Rishen Yu, PHD

Role: CONTACT

0571-87784817

Facility Contacts

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Yiping Chen, PHD

Role: primary

Other Identifiers

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2016-042

Identifier Type: -

Identifier Source: org_study_id

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