Back to resultsMRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
Primary Purpose
Therapeutic Mechanism of Antidepressants for Refractory FD
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Therapeutic Mechanism of Antidepressants for Refractory FD focused on measuring antidepressants, refractory functional dyspepsia, resting fMRI
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.
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
refractory FD patients using antidepressants
refractory FD patienTS using conventional treatment
normal control
Arm Description
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.
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.
Age, sex and education matched, right-handed 30 normal people.
Outcomes
Primary Outcome Measures
Nepean Dyspepsia Index
Evaluation of digestive tract symptoms
Secondary Outcome Measures
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.
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.
The Pittsburgh Sleep Quality Index
Assessment of Sleep Status
quality of life survey questionnaire
Assessment of quality of life
Incidence of Treatment-Emergent Adverse Events
Record any adverse events during treatment
Functional magnetic resonance imaging
assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres
Full Information
NCT ID
NCT03973567
First Posted
May 28, 2019
Last Updated
June 2, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03973567
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Mechanism of Antidepressants for Refractory FD
Keywords
antidepressants, refractory functional dyspepsia, resting fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
refractory FD patients using antidepressants
Arm Type
Experimental
Arm Description
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.
Arm Title
refractory FD patienTS using conventional treatment
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
normal control
Arm Type
No Intervention
Arm Description
Age, sex and education matched, right-handed 30 normal people.
Intervention Type
Drug
Intervention Name(s)
selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants
Intervention Description
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
Other
Intervention Name(s)
conventional therapy
Intervention Description
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.
Primary Outcome Measure Information:
Title
Nepean Dyspepsia Index
Description
Evaluation of digestive tract symptoms
Time Frame
Change from Baseline at 12th week
Secondary Outcome Measure Information:
Title
Zung Self-Rating Anxiety Scale
Description
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.
Time Frame
Change from Baseline at 12th week
Title
Zung Self-Rating Depression Scale
Description
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.
Time Frame
Change from Baseline at 12th week
Title
The Pittsburgh Sleep Quality Index
Description
Assessment of Sleep Status
Time Frame
Change from Baseline at 12th week
Title
quality of life survey questionnaire
Description
Assessment of quality of life
Time Frame
Change from Baseline at 12th week
Title
Incidence of Treatment-Emergent Adverse Events
Description
Record any adverse events during treatment
Time Frame
through study completion, an average of 3 years
Title
Functional magnetic resonance imaging
Description
assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres
Time Frame
baseline and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiping Chen, PHD
Phone
667117
Email
rosechenaz@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rishen Yu, PHD
Phone
0571-87784817
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiping Chen, PHD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiping Chen, PHD
Phone
667117
Email
rosechenaz@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
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