Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-06-23 @ 6:45 AM
Study NCT ID:
NCT03007303
Status:
UNKNOWN
Last Update Posted:
2020-01-30
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D008844', 'term': 'Micrognathism'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'C092292', 'term': 'ziprasidone'}, {'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The peripheral blood sample Plasma separated from the peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2016-12-28', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)', 'timeFrame': 'before the treatment', 'description': 'the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection'}, {'measure': 'the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)', 'timeFrame': 'Change from Baseline expression level at 4-week treatment', 'description': 'the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection'}, {'measure': 'the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)', 'timeFrame': 'Change from Baseline expression level at 8-week treatment', 'description': 'the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection'}], 'secondaryOutcomes': [{'measure': 'the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia', 'timeFrame': 'before, after 4 weeks and 8 weeks treatment', 'description': 'The PANSS for estimating the severity of positive and negative symptoms in schizophrenia'}, {'measure': 'The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia', 'timeFrame': 'before, after 4 weeks and 8 weeks treatment', 'description': 'The degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance'}, {'measure': 'The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment', 'timeFrame': '4 weeks and 8 weeks treatment', 'description': 'Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Micrognathia']}, 'referencesModule': {'references': [{'pmid': '27258654', 'type': 'RESULT', 'citation': 'Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616.'}, {'pmid': '20347265', 'type': 'RESULT', 'citation': 'Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. Epub 2010 Mar 27.'}, {'pmid': '23382797', 'type': 'RESULT', 'citation': 'Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status.', 'detailedDescription': 'The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and the equivalent healthy controls will be conducted with the quantification analysis of the microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).\n\nThe 15 patients enrolled should be the first-episode and have not been treated, or were drug free 3 months recently at least.\n\nThis research measures the expression level of microRNA-30e in schizophrenia respectively before the beginning treatment with atypical psychotics or combined with MECT, after the 4-week treated , the 8-week treated compared with 15 healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons should be diagnosed with schizophrenia according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)\n* The first-onset or drug-free in the latest 3 months\n* Between the ages of 17-40\n\nExclusion Criteria:\n\n* Comorbid with other psychosis\n* Have physical or neurological diseases such as traumatic brain injuries\n* History of drug-abused or alcoholic\n* Blood transfusion history in a month\n* Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months'}, 'identificationModule': {'nctId': 'NCT03007303', 'briefTitle': 'The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': "Dalian Seventh People's Hospital"}, 'orgStudyIdInfo': {'id': 'GFu01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'schizophrenia', 'description': '15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.\n\nThe fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated.', 'interventionNames': ['Drug: Atypical Antipsychotic', 'Other: atypical antipsychotic combined with MECT']}, {'label': 'health controls', 'description': "15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group"}], 'interventions': [{'name': 'Atypical Antipsychotic', 'type': 'DRUG', 'otherNames': ['olanzapine, quetiapine , ziprasidone and risperidone'], 'description': 'Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.', 'armGroupLabels': ['schizophrenia']}, {'name': 'atypical antipsychotic combined with MECT', 'type': 'OTHER', 'otherNames': ['MECT means modified electric convulsive therapy'], 'description': 'The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness', 'armGroupLabels': ['schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116023', 'city': 'Dalian', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanghui Fu, Postgraduate', 'role': 'CONTACT', 'email': 'fuguanghui1023@126.com', 'phone': '86-188 4282 1307'}, {'name': 'Shoufu Xie, Postgraduate', 'role': 'CONTACT', 'email': 'doctorxie1023@126.com', 'phone': '86-0411 8451 4015'}], 'facility': "Dalian Seventh People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'centralContacts': [{'name': 'Guanghui Fu, postgraduate', 'role': 'CONTACT', 'email': 'fuguanghui1023@126.com', 'phone': '86-188 4282 1307'}, {'name': 'Shoufu Xie, postgraduate', 'role': 'CONTACT', 'email': 'doctorxie1023@126.com', 'phone': '86-0411 8451 4015'}], 'overallOfficials': [{'name': 'Shoufu Xie, postgraduate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dalian Seventh People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dalian Seventh People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician，Professor of Psychiatry,Vice president of the hospital', 'investigatorFullName': 'Shoufu Xie', 'investigatorAffiliation': "Dalian Seventh People's Hospital"}}}}