Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-03 @ 9:18 AM
Study NCT ID:
NCT03271866
Status:
UNKNOWN
Last Update Posted:
2023-04-11
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups were observed longitudinally for 24 weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression by CDSS-C', 'timeFrame': '12 weeks', 'description': 'The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C）'}, {'measure': 'Biological markers will be measured by ELISA', 'timeFrame': '12 weeks', 'description': 'The oxidative stress indexes and inflammatory biomarkers will measured by Enzyme-linked Immuno Sorbent Assay (ELISA).'}], 'primaryOutcomes': [{'measure': 'Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score', 'timeFrame': '12 weeks', 'description': 'The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point.'}], 'secondaryOutcomes': [{'measure': 'Change of clinical symptoms by PANSS', 'timeFrame': '12 weeks', 'description': 'The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Metabolic syndrome', 'Metformin', 'Cognitive impairment', 'Clinical trial'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23106932', 'type': 'BACKGROUND', 'citation': 'Lindenmayer JP, Khan A, Kaushik S, Thanju A, Praveen R, Hoffman L, Cherath L, Valdez G, Wance D. Relationship between metabolic syndrome and cognition in patients with schizophrenia. Schizophr Res. 2012 Dec;142(1-3):171-6. doi: 10.1016/j.schres.2012.09.019. Epub 2012 Oct 26.'}, {'pmid': '28032535', 'type': 'BACKGROUND', 'citation': 'Bora E, Akdede BB, Alptekin K. The relationship between cognitive impairment in schizophrenia and metabolic syndrome: a systematic review and meta-analysis. Psychol Med. 2017 Apr;47(6):1030-1040. doi: 10.1017/S0033291716003366. Epub 2016 Dec 29.'}, {'pmid': '25470390', 'type': 'BACKGROUND', 'citation': 'Ying MA, Maruschak N, Mansur R, Carvalho AF, Cha DS, McIntyre RS. Metformin: repurposing opportunities for cognitive and mood dysfunction. CNS Neurol Disord Drug Targets. 2014;13(10):1836-45. doi: 10.2174/1871527313666141130205514.'}, {'pmid': '40597190', 'type': 'DERIVED', 'citation': 'Cai J, Xiao J, Long Y, Cao T, Lin C, Hei G, Wang W, Kang D, Huang J, Shao T, Cai H, Wu R. Metformin-improved cognitive impairment in patients with schizophrenia is correlated with activation of tricarboxylic acid cycle and restored functional connectivity of hippocampus. BMC Med. 2025 Jul 1;23(1):349. doi: 10.1186/s12916-025-04218-4.'}, {'pmid': '37821461', 'type': 'DERIVED', 'citation': 'Shao T, Huang J, Zhao Y, Wang W, Tian X, Hei G, Kang D, Gao Y, Liu F, Zhao J, Liu B, Yuan TF, Wu R. Metformin improves cognitive impairment in patients with schizophrenia: associated with enhanced functional connectivity of dorsolateral prefrontal cortex. Transl Psychiatry. 2023 Oct 11;13(1):315. doi: 10.1038/s41398-023-02616-x.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) for 24 weeks. Clinical assessment will be done at screen/baseline, 4 weeks, 12 weeks, and 24 weeks. The specific aims are to compare the metformin group versus controls on 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms.', 'detailedDescription': 'In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) . Clinical assessment will be done at screen/baseline, 4 week, 12 week and 24 week. The specific aims are to compare the metformin group versus controls on: 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms. Clinical symptoms will be measured by the Positive and Negative Syndrome Scale and Calgary Depression Scale for Schizophrenia (Chinese version). Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery.\n\nThe investigators hypothesize that 1) metformin may improve the cognitive impairment of schizophrenia patients; 2) metformin may alter oxidative stress indexes or inflammatory biomarkers thus influencing the oxidative and inflammatory mechanism, and the structure and function of the hippocampus that may be significantly associated with cognitive function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;\n2. Duration of illness less than 5 years with current symptoms exacerbation;\n3. Male and female aged 18 to 65 years;\n4. PANSS total score \\< 60 and CDSS-C total score \\< 6;\n5. Signed the study consent for participation;\n6. Patients with higher risk factors for MetS, or patients who gained weight \\> 10% of their pre-drug weight within the first year after antipsychotic medication.\n\nExclusion Criteria:\n\n1. Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;\n2. Having a history of traumatic brain injury, seizures, or other known neurological or organic diseases of the central nervous system;\n3. Taking antidepressants, stimulants, mood stabilizers or accepting electricity shock treatment;\n4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting;\n5. The routine blood tests showing abnormal renal, and liver function;\n6. Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT03271866', 'briefTitle': 'Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Effect of Metformin Treatment on Cognitive Impairment in Patients With Schizophrenia Co-morbid Metabolic Syndrome: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'WU201708MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'metformin treatment', 'interventionNames': ['Drug: metformin']}, {'type': 'NO_INTERVENTION', 'label': 'non-metformin treatment'}], 'interventions': [{'name': 'metformin', 'type': 'DRUG', 'description': 'metformin 1500mg per day', 'armGroupLabels': ['metformin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tiannan Shao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'shaostndoc@163.com', 'phone': '+86 13341318057'}, {'name': 'Renrong Wu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'wurenrong2013@163.com'}, {'name': 'Dongyu Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Tiannan Shao, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'shaostndoc@163.com', 'phone': '+86 13341318057'}], 'overallOfficials': [{'name': 'Tiannan Shao, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}, {'name': 'Dongyu Kang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}, {'name': 'Renrong Wu, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renrong Wu', 'investigatorAffiliation': 'Central South University'}}}}