Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-28 @ 2:35 PM
Study NCT ID:
NCT07062666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017367', 'term': 'Selective Serotonin Reuptake Inhibitors'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fNIRS', 'timeFrame': '2024～2025', 'description': 'Sensitivity and specificity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['the Objective Diagnosis of Depression']}, 'descriptionModule': {'briefSummary': 'This study intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group, and using eye tracking technology to detect the eye movement characteristics of patients with depression before treatment and in the gender - and age-matched control group. The sensitivity and specificity of fNIRS spectrum and eye movement index in objective diagnosis of patients with depressive disorder were calculated, and according to the HAMD reduction rate, depression patients after 2 weeks of treatment were divided into remission group and non-remission group. fNIRS imaging and eye movement indexes in depression group and normal control group were compared, fNIRS imaging and eye movement indexes in depression remission group before and after treatment, fNIRS imaging and eye movement indexes in depression remission group and non-remission group were compared at baseline to verify the biomarkers of fNIRS spectrum and eye movement indexes in predicting antidepressant efficacy. Finally, it provides reliable scientific evidence for the important role of fNIRS imaging and eye tracking technology in the diagnosis and treatment of depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'depressive patients', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-60 years old; ② Right-handed; ③ Meet the DSM-5 diagnostic criteria for depression; ④ The current course of disease (last onset) is at least 2 weeks; ⑤HAMD-17 score ≥17 points; ⑥ No electroconvulsive therapy was received in the first six months.\n\nExclusion Criteria:\n\n* A combination of another mental illness; A history of alcohol/drug dependence or smoking \\> 10 cigarettes/day; ③ Serious physical diseases of the heart, liver, kidney, brain and hematopoietic system, central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease or intracranial tumors; ④ Family history of hereditary diseases; ⑤Endocrine system diseases such as diabetes, hyperthyroidism or hypothyroidism; ⑥ Pregnant, lactating women or photosensitivities."}, 'identificationModule': {'nctId': 'NCT07062666', 'briefTitle': 'A Multicentre Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'A Multicentre Clinical Study of Near Infrared Functional Brain Imaging Combined With Eye Tracking Technique for the Auxiliary Diagnosis and Treatment Effect Prediction of Depression', 'orgStudyIdInfo': {'id': 'MR-32-25-015243'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'depressive patients', 'interventionNames': ['Drug: SSRIs', 'Device: fNIRS']}, {'label': 'controls', 'interventionNames': ['Device: fNIRS']}], 'interventions': [{'name': 'SSRIs', 'type': 'DRUG', 'description': 'take SSRIs for 2 weeks', 'armGroupLabels': ['depressive patients']}, {'name': 'fNIRS', 'type': 'DEVICE', 'description': 'All subjects receive fNIRS examination.', 'armGroupLabels': ['controls', 'depressive patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of Scientific Committee', 'investigatorFullName': 'Yonggui Yuan', 'investigatorAffiliation': 'Zhongda Hospital'}}}}