Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 7:01 PM
Study NCT ID:
NCT06580860
Status:
RECRUITING
Last Update Posted:
2024-09-05
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Multi-omics and Neuroimaging Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014150', 'term': 'Antipsychotic Agents'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}], 'ancestors': [{'id': 'D014149', 'term': 'Tranquilizing Agents'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '10ml peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1899}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cortical morphology', 'timeFrame': '40 minutes', 'description': 'Data were obtained using magnetic resonance scans'}, {'measure': 'target gene charaacteristics', 'timeFrame': '1 day', 'description': '10ml peripheral blood was extracted for gene analysis'}, {'measure': 'scale scores', 'timeFrame': '90 minutes.', 'description': 'The score of each dimension and the total score were calculated according to the scale.The scale includes three dimensions: negative symptom, positive symptom and general psychopathology, and the score range of each dimension is different. The total score ranges from 30 to 210, with higher scores indicating worse results.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'major depressive disorder', 'autism spectrum disorder', 'bipolar disorder', 'magnetic resonance imaging', 'multi-omics'], 'conditions': ['Mental Disorders', 'Healthy Control']}, 'descriptionModule': {'briefSummary': 'This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.', 'detailedDescription': 'The study seeks to identify possible biological markers of schizophrenia and the effects of gene-environment interactions on brain structural and functional networks. So we can help doctors and scientific researchers better understand the neuropathological basis of schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '13 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from inpatient and outpatient the second Xiangya Hosptial of Central South University, Healthy controls from community, school and street recruitment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 13-35 years old(Patients with healthy siblings can be extended to 14-35 years of age)\n* Course of disease: \\<24 months\n* Priority is given to patients who have never taken medicine or duration of drug use \\< 2 weeks\n* No nuclear magnetic contraindications.\n\nExclusion Criteria:\n\n* Family history of psychotic disorders, history of psychoactive substances abuse, alcohol dependence, or nicotine dependence\n* Have a major physical disease or infectious disease\n* History of coma and serious neurological disease 4.MRI contraindications.'}, 'identificationModule': {'nctId': 'NCT06580860', 'acronym': 'PMNP', 'briefTitle': 'Psychiatric Multi-omics and Neuroimaging Project', 'organization': {'class': 'OTHER', 'fullName': 'Second Xiangya Hospital of Central South University'}, 'officialTitle': 'Psychiatric Multi-omics and Neuroimaging Project Database', 'orgStudyIdInfo': {'id': 'NSFC82201664'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PMNP-Healthy Norms', 'description': 'Healthy Norms', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}, {'label': 'PMNP-Subclinical high-risk', 'description': 'Subclinical high-risk', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}, {'label': 'PMNP-Schizophrenia and Psychosis', 'description': 'Schizophrenia and Psychosis patient', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}, {'label': 'PMNP-MDD', 'description': 'major depressive disorder patient', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}, {'label': 'PMNP-ASD', 'description': 'autism spectrum disorder patient', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}, {'label': 'PMNP-BD', 'description': 'bipolar disorder patient', 'interventionNames': ['Drug: Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids']}], 'interventions': [{'name': 'Antipsychotic drugs, antidepressants, mood stabilizers, and sleep aids', 'type': 'DRUG', 'description': 'Patients with mental disorders should take the appropriate medicine as prescribed by the doctor，and the health norms are not required to take medicine.This study will not interfere with the medication regimen of doctors.', 'armGroupLabels': ['PMNP-ASD', 'PMNP-BD', 'PMNP-Healthy Norms', 'PMNP-MDD', 'PMNP-Schizophrenia and Psychosis', 'PMNP-Subclinical high-risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunzhi Pan', 'role': 'CONTACT', 'email': 'panyunzhi@csu.edu.cn', 'phone': '15074818197'}], 'facility': 'The Second Xiangya hospital of central south univerity', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yunzhi Pan', 'role': 'CONTACT', 'email': 'panyunzhi@csu.edu.cn', 'phone': '15074818197'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mingjun Zhong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'mingjun Zhong', 'investigatorAffiliation': 'Second Xiangya Hospital of Central South University'}}}}