Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00807105
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-04', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response in HAMDS', 'timeFrame': '1 YEAR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MOOD EVALUATION'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This is a prospective open label study of acute and maintenance treatment of MDD. The acute phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight weeks followed by 10 weeks of once a week treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MDD patients\n\nExclusion Criteria:\n\n* risk factors for convulsions'}, 'identificationModule': {'nctId': 'NCT00807105', 'briefTitle': 'Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'orgStudyIdInfo': {'id': '0013-07 SHA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'depressive patients', 'description': 'patients suffering from deppresion', 'interventionNames': ['Device: H-coil dTMS']}], 'interventions': [{'name': 'H-coil dTMS', 'type': 'DEVICE', 'description': 'treatment with deep TMS stimulation.', 'armGroupLabels': ['depressive patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'state': 'Israel', 'country': 'Israel', 'facility': 'ShalvataMHC', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brainsway', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}