Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03973567
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}, {'id': 'D000068760', 'term': 'Serotonin and Noradrenaline Reuptake Inhibitors'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}], 'ancestors': [{'id': 'D014179', 'term': 'Neurotransmitter Uptake Inhibitors'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-02', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-02', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nepean Dyspepsia Index', 'timeFrame': 'Change from Baseline at 12th week', 'description': 'Evaluation of digestive tract symptoms'}], 'secondaryOutcomes': [{'measure': 'Zung Self-Rating Anxiety Scale', 'timeFrame': 'Change from Baseline at 12th week', '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.'}, {'measure': 'Zung Self-Rating Depression Scale', 'timeFrame': 'Change from Baseline at 12th week', '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.'}, {'measure': 'The Pittsburgh Sleep Quality Index', 'timeFrame': 'Change from Baseline at 12th week', 'description': 'Assessment of Sleep Status'}, {'measure': 'quality of life survey questionnaire', 'timeFrame': 'Change from Baseline at 12th week', 'description': 'Assessment of quality of life'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Record any adverse events during treatment'}, {'measure': 'Functional magnetic resonance imaging', 'timeFrame': 'baseline and 12th week', 'description': 'assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antidepressants', 'refractory functional dyspepsia', 'resting fMRI'], 'conditions': ['Therapeutic Mechanism of Antidepressants for Refractory FD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-60 years old, meeting the criteria for inclusion of refractory FD\n* HP infection negative\n* Right handedness\n\nExclusion Criteria:\n\n* Antidepressant drug allergists\n* History of gastroduodenal surgery;\n* Researchers judged suicidal ideation.\n* Women in pregnancy or lactation.\n* Patients with uncorrected narrow angle glaucoma.\n* There was a history of epileptic seizures.\n* suffering from any serious or unstable medical disease or disease.\n* Addiction to illicit drugs or alcohol and unwillingness to discontinue use during the study period.\n* Patients can't express their complaints correctly and can't cooperate with the researcher."}, 'identificationModule': {'nctId': 'NCT03973567', 'briefTitle': 'MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia', 'orgStudyIdInfo': {'id': '2016-042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'refractory FD patients using antidepressants', '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.', 'interventionNames': ['Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'refractory FD patienTS using conventional treatment', '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.', 'interventionNames': ['Other: conventional therapy']}, {'type': 'NO_INTERVENTION', 'label': 'normal control', 'description': 'Age, sex and education matched, right-handed 30 normal people.'}], 'interventions': [{'name': 'selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants', 'type': 'DRUG', '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.', 'armGroupLabels': ['refractory FD patients using antidepressants']}, {'name': 'conventional therapy', 'type': 'OTHER', 'description': 'Anti-HP, acid suppression, gastrointestinal motility regulation, etc.', 'armGroupLabels': ['refractory FD patienTS using conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yiping Chen, PHD', 'role': 'CONTACT', 'email': 'rosechenaz@163.com', 'phone': '667117'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yiping Chen, PHD', 'role': 'CONTACT', 'email': 'rosechenaz@163.com', 'phone': '667117'}, {'name': 'Rishen Yu, PHD', 'role': 'CONTACT', 'phone': '0571-87784817'}], 'overallOfficials': [{'name': 'Yiping Chen, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}