MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

June 2, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rishen Yu, PHD
  • Phone Number: 0571-87784817

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
PLACEBO_COMPARATOR: 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.
Other: conventional therapy
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.
NO_INTERVENTION: normal control
Age, sex and education matched, right-handed 30 normal people.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nepean Dyspepsia Index
Time Frame: Change from Baseline at 12th week
Evaluation of digestive tract symptoms
Change from Baseline at 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zung Self-Rating Anxiety Scale
Time Frame: 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.
Change from Baseline at 12th week
Zung Self-Rating Depression Scale
Time Frame: 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.
Change from Baseline at 12th week
The Pittsburgh Sleep Quality Index
Time Frame: Change from Baseline at 12th week
Assessment of Sleep Status
Change from Baseline at 12th week
quality of life survey questionnaire
Time Frame: Change from Baseline at 12th week
Assessment of quality of life
Change from Baseline at 12th week
Incidence of Treatment-Emergent Adverse Events
Time Frame: through study completion, an average of 3 years
Record any adverse events during treatment
through study completion, an average of 3 years
Functional magnetic resonance imaging
Time Frame: baseline and 12th week
assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres
baseline and 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Yiping Chen, PHD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 2, 2019

First Posted (ACTUAL)

June 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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