Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT05086133
Status:
UNKNOWN
Last Update Posted:
2022-11-17
First Post:
2021-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cTBS on First-episode Drug Naive Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1 group for intervention and 1 group for sham stimulation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three-Factor Eating Questionnaire', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'min value 21, max value 84. The higher scores mean more unhealthy eating behavior.'}, {'measure': 'MCCB', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'The MATRICS™ Consensus Cognitive Battery'}, {'measure': 'The positive and negative syndrome scale', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'min score 30, max score 210. The higher score means more severe symptoms.'}, {'measure': 'BMI', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'body mass index'}], 'secondaryOutcomes': [{'measure': 'Resting EEG', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.'}, {'measure': 'fasting glucose', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'in mmol/l'}, {'measure': 'Triglyceride', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'in mmol/l'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'in mmol/l'}, {'measure': 'Low Density Lipoprotein', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'in mmol/l'}, {'measure': 'High Density Lipoprotein', 'timeFrame': 'Change from Baseline to 6days and 36days', 'description': 'in mmol/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '38272892', 'type': 'DERIVED', 'citation': 'Kang D, Song C, Peng X, Yu G, Yang Y, Chen C, Long Y, Shao P, Wu R. The effect of continuous theta burst stimulation on antipsychotic-induced weight gain in first-episode drug-naive individuals with schizophrenia: a double-blind, randomized, sham-controlled feasibility trial. Transl Psychiatry. 2024 Jan 25;14(1):61. doi: 10.1038/s41398-024-02770-w.'}, {'pmid': '37921353', 'type': 'DERIVED', 'citation': 'Kang D, Zhang Y, Wu G, Song C, Peng X, Long Y, Yu G, Tang H, Gui Y, Wang Q, Yuan T, Wu R. The Effect of Accelerated Continuous Theta Burst Stimulation on Weight Loss in Overweight Individuals With Schizophrenia: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. Schizophr Bull. 2024 Apr 30;50(3):589-599. doi: 10.1093/schbul/sbad144.'}]}, 'descriptionModule': {'briefSummary': 'cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.\n\nTherefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.', 'detailedDescription': 'cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.\n\nTherefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with schizophrenia in accordance with DSM-5\n* The course of the disease less then 2 years\n* Accepting antipsychotics treatment for less then 2 months\n\nExclusion Criteria:\n\n* Diagnosed with other mental disease in accordance with DSM-5\n* Comorbid with other severe physiological disease\n* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before\n* Drug or alcohol abuse\n* Pregnant or lactating Contraindication to rTMS'}, 'identificationModule': {'nctId': 'NCT05086133', 'briefTitle': 'cTBS on First-episode Drug Naive Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'WU2021TBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cTBS stimulation', 'description': 'The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.', 'interventionNames': ['Device: transcranial magnetic stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.', 'armGroupLabels': ['cTBS stimulation']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'description': 'TMS coil vertical to the brain surface, with same protocol as cTBS', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renrong Wu', 'investigatorAffiliation': 'Central South University'}}}}