Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00515658
Status:
UNKNOWN
Last Update Posted:
2007-08-14
First Post:
2007-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antidepressant Effect of Theta-Burst rTMS
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-13', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-13', 'lastUpdatePostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major depression', 'Theta-burst rTMS', 'Cortical excitability', 'Hamilton depression rating scale'], 'conditions': ['Major Depression']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients with major depression. Patients will be randomized to receive ether left-sided intermittent theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two weeks period with an option for an additional two weeks period, depending on treatment response. Clinical assessments will be performed weekly by the Hamilton depression rating scale. In addition, standard neurophysiological assessment of cortical excitability will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depressive episode (DSM IV criteria).\n* Informed consent.\n* Age: 18-70.\n\nExclusion Criteria:\n\n* Suicidality\n* Psychosis\n* Pacemaker\n* Cardiac arrythmia\n* seizure disorder\n* implantable metal devices\n* PNS and CNS disorders\n* any other contraindications as specified in safety guidelines for rTMS (Wassermenn, 1998).'}, 'identificationModule': {'nctId': 'NCT00515658', 'briefTitle': 'Antidepressant Effect of Theta-Burst rTMS', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Antidepressant Effect of Theta-Burst rTMS', 'orgStudyIdInfo': {'id': 'Rambam2141_CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'theta-burst rTMS', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ehud Klein, MD', 'role': 'CONTACT', 'email': 'e_klein@rambam.health.gov.il', 'phone': '972-4-8542559'}, {'name': 'Andrei Chistyakov, PhD', 'role': 'CONTACT', 'email': 'a_chistyakov@rambam.health.gov.il', 'phone': '972-4-8543695'}, {'name': 'Ehud Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrei Chistyakov, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ehud Klein, MD', 'role': 'CONTACT', 'email': 'e_klein@rambam.health.gov.il', 'phone': '972-4-8543599'}, {'name': 'Andrei Chistyakov, PhD', 'role': 'CONTACT', 'email': 'a_chistyakov@rambam.health.gov.il', 'phone': '972-4-8543695'}], 'overallOfficials': [{'name': 'Ehud Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}