Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 4:00 AM
Study NCT ID:
NCT01909232
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2015-06-23', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2013-07-22', 'dispFirstSubmitQcDate': '2015-06-23', 'studyFirstSubmitQcDate': '2013-07-24', 'dispFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression severity', 'timeFrame': 'Baseline to four weeks (the conclusion of rTMS treatment)', 'description': 'Measured by the 24-item Hamilton Rating Scale for Depression'}], 'secondaryOutcomes': [{'measure': 'Change in depression severity', 'timeFrame': 'Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)', 'description': 'Measured by the 24-item Hamilton Rating Scale for Depression'}, {'measure': 'Clinically significant response', 'timeFrame': 'Baseline to four weeks (the conclusion of rTMS treatment)', 'description': 'Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score'}, {'measure': 'Clinically significant response', 'timeFrame': 'Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)', 'description': 'Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score'}, {'measure': 'Remission from depression', 'timeFrame': 'Baseline to four weeks (the conclusion of rTMS treatment)', 'description': 'Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10'}, {'measure': 'Remission from depression', 'timeFrame': 'Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)', 'description': 'Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline to four weeks (the conclusion of rTMS treatment)', 'description': 'Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)', 'description': 'Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form'}, {'measure': 'Incidence of treatment-emergent adverse events and serious adverse events', 'timeFrame': 'Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Depressive Disorder', 'Major depression', 'Major depressive disorder', 'MDD', 'Treatment resistant depression', 'Treatment intolerant depression', 'TRMD', 'TIMD', 'Transcranial Magnetic Stimulation', 'TMS'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cervel.com', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current major depressive disorder (MDD)\n* Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode\n* On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study\n* Weight less than 350 pounds\n\nExclusion Criteria:\n\n* Current major depressive disorder episode of more than three years\n* Seizure disorder\n* History of brain injury, stroke or active central nervous system disease\n* Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe\n* Active suicidal intent or plan\n* Other significant psychiatric disorder\n* Alcohol or substance dependence or abuse\n* Prior treatment with transcranial magnetic stimulation\n* Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation\n* If female, pregnant or lactating or planning to become pregnant within the next three months'}, 'identificationModule': {'nctId': 'NCT01909232', 'briefTitle': 'A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cervel Neurotech, Inc.'}, 'officialTitle': 'A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'CN-CFS-TRMD-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active rTMS treatment', 'description': 'Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator', 'interventionNames': ['Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS treatment', 'description': 'Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator', 'interventionNames': ['Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator']}], 'interventions': [{'name': 'Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator', 'type': 'DEVICE', 'description': 'The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.', 'armGroupLabels': ['Active rTMS treatment']}, {'name': 'Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator', 'type': 'DEVICE', 'description': 'The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.', 'armGroupLabels': ['Sham rTMS treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30306', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21285', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sheppard-Pratt Health System', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'CRI Lifetree', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Beth Stannard, BS, CCRP, CCRC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cervel Neurotech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cervel Neurotech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}