Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-01 @ 9:55 PM
Study NCT ID:
NCT02202460
Status:
UNKNOWN
Last Update Posted:
2014-07-29
First Post:
2014-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-25', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-07-25', 'lastUpdatePostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brain MRI', 'timeFrame': '18 month', 'description': 'Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.'}], 'primaryOutcomes': [{'measure': 'Oxidative Stress-related Immunological Factors', 'timeFrame': '18 month', 'description': 'Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFα,TGFβ， MCP-1，IL-1α，IL-2，IL-6，IL-10，IL-12.'}], 'secondaryOutcomes': [{'measure': 'BDNF', 'timeFrame': '18 month', 'description': "Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Other Immunological States or Disorders']}, 'descriptionModule': {'briefSummary': 'Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.', 'detailedDescription': 'Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Schizophrenia , Bipolar Disorder , Major Depression', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5\n\nExclusion Criteria:\n\n* Unstable physical conditions'}, 'identificationModule': {'nctId': 'NCT02202460', 'briefTitle': 'The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.', 'orgStudyIdInfo': {'id': 'rrw2014'}, 'secondaryIdInfos': [{'id': 'IFMISMD', 'type': 'REGISTRY', 'domain': 'IFMISMD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Renrong Wu, PhD', 'role': 'CONTACT', 'email': 'wurenrong2013@163.com', 'phone': '15874179855'}], 'facility': 'Mental Health Institute of 2nd Xiangya Hospital,CSU', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Renrong Wu, PhD', 'role': 'CONTACT', 'email': 'wurenrong2013@163.com', 'phone': '+86 15874179855'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renrong Wu', 'investigatorAffiliation': 'Central South University'}}}}