Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:42 AM
Study NCT ID:
NCT07479758
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of gamma-aminobutyric acid (GABA) in visual cortex', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Concentration of GABA in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)'}, {'measure': 'Concentration of glutamate (Glu) in visual cortex', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Concentration of Glu in the middle temporal visual cortex complex (MT+) and primary visual cortex (V1) measured via 7T magnetic resonance spectroscopy (MRS).Unit of Measure: Millimolar (mM)'}], 'secondaryOutcomes': [{'measure': 'Severity of depressive symptoms in MDD patients', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Clinical symptom severity as measured by the Hamilton Depression Rating Scale (HAMD).Unit of Measure: Total score on HAMD scale (Range 0-52, higher scores indicate greater severity).'}, {'measure': 'Severity of psychotic symptoms in SZ patients', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Clinical symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Unit of Measure: Total score on PANSS scale (Range 30-210, higher scores indicate greater severity).'}, {'measure': 'Severity of manic symptoms in BD patients', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Clinical symptom severity as measured by the Young Mania Rating Scale (YMRS).Unit of Measure: Total score on YMRS scale (Range 0-60, higher scores indicate greater severity).'}, {'measure': 'Visual motion perception speed', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Performance in visual motion perception assessed using standardized psychophysical experiments.Unit of Measure: Degrees per second (°/s) or threshold values'}, {'measure': 'Binocular rivalry perceptual switching rate', 'timeFrame': 'Baseline and 4 weeks post-treatment', 'description': 'Perceptual switching rate during binocular rivalry task assessed via psychophysical experiments.Unit of Measure: Number of switches per minute'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultra-High-Field MRI', 'Visual Perception', 'Magnetic Resonance Spectroscopy', 'Mental Health Biomarkers'], 'conditions': ['Major Depressive Disorder (MDD)', 'Schizophrenia', 'Bipolar Disorder', 'Severe Mental Disorders']}, 'descriptionModule': {'briefSummary': 'This is an observational study aiming to screen biomarkers associated with the diagnosis and treatment outcomes of severe mental disorders (MDD/major depressive disorder, SZ/schizophrenia, BD/bipolar disorder) through 7T ultra-high-field magnetic resonance multimodal imaging and visual perception assessment, thereby optimizing the objectivity and precision of clinical diagnosis and treatment.\n\nI. Core Research Objectives\n\n1. Clarify the specific changes in visual perception behavior and brain imaging (metabolism, functional connectivity) of patients with severe mental disorders before and after treatment.\n2. Establish a biomarker system related to disease diagnosis and treatment outcomes to make up for the limitation of current clinical reliance on phenomenological diagnosis.\n\nII. Study Subjects and Inclusion/Exclusion Criteria\n\n1. Recruitment Scope\n\n * Patient group: MDD, SZ, and BD patients diagnosed in the Department of Psychiatry, the Second Affiliated Hospital of Zhejiang University School of Medicine.\n * Healthy control group: Healthy individuals without a history of mental illness recruited from the general population.\n2. Key Criteria\n\n * Inclusion: Aged 18-45 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria (for the patient group); no organic brain injury or severe physical illness; signing the informed consent form.\n * Exclusion: Organic brain diseases; severe physical illnesses (e.g., tumors); internal metal implants (e.g., cardiac pacemakers); claustrophobia or inability to tolerate MR examinations; pregnancy, etc.\n\nIII. Core Study Procedures\n\n1. All participants will undergo 2 sessions of 7T MRI scans (including MRS, fMRI, and other multimodal sequences), focusing on the MT+ brain region and V1 brain region respectively, with the scan order randomly balanced.\n2. During the interval between the two MRI scans, participants will complete visual psychophysical experiments, cognitive function tests (e.g., BDT test), and clinical symptom collection.\n3. The study will not interfere with routine clinical treatment and strictly adheres to the ethical standards of the Second Affiliated Hospital of Zhejiang University School of Medicine (Ethical Approval No.: 2025 Lun Shen Yan Di 0603).\n\nIV. Study Significance\n\n1. Provide objective biomarkers for clinical practice to improve the accuracy of diagnosis and the scientificity of treatment effect evaluation for severe mental disorders.\n2. Reveal the association mechanism between visual cortex-related brain networks and diseases, laying a theoretical foundation for precision diagnosis and treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient Group: Recruited from the Department of Psychiatry at The Second Affiliated Hospital of Zhejiang University School of Medicine, consisting of three subgroups: patients with major depressive disorder (MDD), schizophrenia (SZ), and bipolar disorder (BD), all meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria.\n\nHealthy Control (HC) Group: Recruited from the general public, with no history of mental disorder diagnosis.\n\nAll participants are aged 18 to 45 years (inclusive), meet the study's inclusion/exclusion criteria (no severe physical illnesses, no organic brain injury, etc.), and will complete non-invasive assessments (7T MRI scans, visual psychophysical experiments, cognitive tests, and clinical symptom evaluations) as required. The patient group receives standard clinical treatment (no study-induced intervention) during the study period.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 18 to 45 years old at the time of enrollment\n* Male or female participants\n* For patients: A diagnosis of major depressive disorder (MDD), schizophrenia (SZ), or bipolar disorder (BD) based on DSM-5 criteria\n* For healthy controls: No history of any mental health disorders\n* No current severe medical illnesses or history of brain injury such as encephalitis\n* Ability to provide written informed consent by the participant or their guardian\n\nExclusion Criteria:\n\n* History of head injury or brain diseases such as epilepsy\n* Presence of severe physical illnesses such as tumors or thyroid problems\n* Presence of metal implants in the body like pacemakers or brain devices\n* Fear of enclosed spaces (claustrophobia) or inability to undergo an MRI scan\n* Current pregnancy'}, 'identificationModule': {'nctId': 'NCT07479758', 'briefTitle': 'Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Outcomes of Severe Mental Disorders', 'orgStudyIdInfo': {'id': '2025-11-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control (HC)', 'description': 'Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).'}, {'label': 'Major Depressive Disorder (MDD)', 'description': 'Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for MDD; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments (pre- and post-treatment 7T MRI, behavioral tests).'}, {'label': 'Schizophrenia (SZ)', 'description': 'Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for schizophrenia; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.'}, {'label': 'Bipolar Disorder (BD)', 'description': 'Recruited from Psychiatry Department of the Second Affiliated Hospital of Zhejiang University; meet DSM-5 diagnostic criteria for bipolar disorder; other inclusion/exclusion criteria consistent with Healthy Control group; receive standard clinical treatment (no study intervention), complete required assessments.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Lin', 'role': 'CONTACT', 'email': 'Linzzr@126.com', 'phone': '86-13757118261'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zheng Lin', 'role': 'CONTACT', 'email': 'Linzzr@126.com', 'phone': '86-13757118261'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}