Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-28 @ 5:20 PM
Study NCT ID:
NCT01198561
Status:
UNKNOWN
Last Update Posted:
2015-12-31
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma and DNAs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton depression rating scale (HAM-D 17)', 'timeFrame': 'baseline, 1, 2, and 4 weeks after TMS', 'description': 'measuring instrument of severity of depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['repetitive Transcranial Magnetic Stimulation', 'Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.', 'detailedDescription': 'The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with major depressive disorder, who were not responsive to antidepressants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.\n* Antidepressant medication will be maintained throughout the study period.\n\nExclusion Criteria:\n\n* Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.\n* To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.'}, 'identificationModule': {'nctId': 'NCT01198561', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism', 'orgStudyIdInfo': {'id': '2005-08-072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'repetitive Transcranial Magnetic Stimulation', 'description': 'repetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS', 'interventionNames': ['Device: repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': '10 times repetitive TMS, high frequency', 'armGroupLabels': ['repetitive Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Kangnam-Ku', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Doh Kwan Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'paulkim@skku.edu', 'phone': '82-2-3410-3582'}, {'name': 'Doh Kwan Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Doh Kwan Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'paulkim@skku.edu', 'phone': '82-2-3410-3582'}], 'overallOfficials': [{'name': 'Doh K KIm, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D. / Professor', 'investigatorFullName': 'Doh Kwan Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}