Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 3:48 PM
Study NCT ID:
NCT01170520
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-04', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Depression Rating Scale (CDRS) comparison before after therapy', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'keywords': ['adolescent resistant depression', 'repetitive transcranial magnetic stimulation', 'treatment of resistant adolescent depression'], 'conditions': ['Adolescent Depression']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.\n\nA group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 15-18 years old\n* Right hand dominant\n* Suffering from major depression\n* CDRS \\> 60\n* At least 3 months of current depressive episode\n* Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy\n* No contraindication for rtms (safety questionnaire)\n* No change in pharmacotherapy in the last month\n\nExclusion Criteria:\n\n* Schizophrenia or psychotic symptoms\n* Hypertension\n* Epilepsy\n* History of major head trauma\n* Metal implements in the head\n* History of neurosurgery\n* History of severe head migraine\n* History of hearing loss or sp cochlear transplantation\n* Pregnancy\n* Current drug abuse\n* Unstable medical condition\n* History of manic episode\n* Current treatment with lithium or tricyclic or tetracyclic antidepressants'}, 'identificationModule': {'nctId': 'NCT01170520', 'briefTitle': 'Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'officialTitle': 'The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study', 'orgStudyIdInfo': {'id': 'HT 4953'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS', 'interventionNames': ['Device: repetitive transcranial Stimulation']}], 'interventions': [{'name': 'repetitive transcranial Stimulation', 'type': 'DEVICE', 'description': 'rTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec.', 'armGroupLabels': ['rTMS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yuval Bloch, MD', 'role': 'CONTACT', 'phone': '972-97478644'}, {'name': 'Yuval Bloch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shalvata Mental health Center', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}, {'city': 'Hod HaSharon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yuval Bloch, MD', 'role': 'CONTACT', 'email': 'yuvalbl@clalit.org.il', 'phone': '972-9-7478510'}], 'facility': 'Shalvata Mental Health Center', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'centralContacts': [{'name': 'Yuval Bloch, MD', 'role': 'CONTACT', 'email': 'yuvalbl@clalit.org.il; aviva100@bezeqint.net', 'phone': '972-506264628'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}