Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-27 @ 4:42 AM
Study NCT ID:
NCT00186758
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation in Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare antidepressant efficacy of right, left to sham', 'timeFrame': 'within 9 weeks'}], 'secondaryOutcomes': [{'measure': 'To determine if QEEG activity correlates with antidepressant response to rTMS', 'timeFrame': 'within 9 weeks'}, {'measure': 'To determine if non-responders can become responders if treating the opposite hemisphere', 'timeFrame': 'within 9 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transcranial Magnetic Stimulation', 'TMS'], 'conditions': ['Bipolar Affective Disorder']}, 'descriptionModule': {'briefSummary': 'To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)\n\nto determine if non-responders can become responders if treated on the other side of the hemisphere\n\n(rTMS)', 'detailedDescription': 'Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar Depression\n* no physical health problems\n\nExclusion Criteria:\n\n* Metal in head/neck or skull\n* History of Epilepsy\n* Pregnancy\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT00186758', 'acronym': 'TMS', 'briefTitle': 'Transcranial Magnetic Stimulation in Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression', 'orgStudyIdInfo': {'id': 'TMS2092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1, Phase l, True or Sham', 'description': 'this treatment will be True or Sham (placebo) on one side of the head, phase I', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2, phase ll, Sham or True', 'description': 'This treatment will be Sham(placebo)or True on the other side of the head phase II.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation (TMS)']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'otherNames': ['HamD', 'BDI II', 'VAS'], 'description': 'Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.\n\nPhase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -', 'armGroupLabels': ['1, Phase l, True or Sham', '2, phase ll, Sham or True']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3K7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Gary Hasey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'collaborators': [{'name': "Queen's University, Kingston, Ontario", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Gary Hasey, Director, TMS Laboratory', 'oldOrganization': 'McMaster University'}}}}