Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 5:53 AM
Study NCT ID:
NCT01409304
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2011-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Deep Transcranial Magnetic Stimulation in Depression
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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '21-item Hamilton Depression Rating Scale (HAM-D21)', 'timeFrame': 'week 5', 'description': 'Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 9.'}], 'secondaryOutcomes': [{'measure': 'Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)', 'timeFrame': 'week 5', 'description': 'Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score ≤ 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major depression', 'Deep Transcranial Magnetic Stimulation', 'Naturalistic Trial', 'DTMS'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '20663568', 'type': 'BACKGROUND', 'citation': 'Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.'}, {'pmid': '20633419', 'type': 'BACKGROUND', 'citation': 'Levkovitz Y, Harel EV, Roth Y, Braw Y, Most D, Katz LN, Sheer A, Gersner R, Zangen A. Deep transcranial magnetic stimulation over the prefrontal cortex: evaluation of antidepressant and cognitive effects in depressive patients. Brain Stimul. 2009 Oct;2(4):188-200. doi: 10.1016/j.brs.2009.08.002. Epub 2009 Sep 16.'}, {'pmid': '17977787', 'type': 'BACKGROUND', 'citation': 'Levkovitz Y, Roth Y, Harel EV, Braw Y, Sheer A, Zangen A. A randomized controlled feasibility and safety study of deep transcranial magnetic stimulation. Clin Neurophysiol. 2007 Dec;118(12):2730-44. doi: 10.1016/j.clinph.2007.09.061. Epub 2007 Oct 30.'}, {'pmid': '24486892', 'type': 'DERIVED', 'citation': 'McGirr A, Van den Eynde F, Chachamovich E, Fleck MP, Berlim MT. Personality dimensions and deep repetitive transcranial magnetic stimulation (DTMS) for treatment-resistant depression: a pilot trial on five-factor prediction of antidepressant response. Neurosci Lett. 2014 Mar 20;563:144-8. doi: 10.1016/j.neulet.2014.01.037. Epub 2014 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'We intend to investigate whether deep transcranial magnetic stimulation (DTMS), a novel brain stimulation technique, is effective for treating major depression. We hypothesize that 4 weeks of DTMS will be associated with significant improvements in depressive and anxious symptoms without significant side effects.', 'detailedDescription': 'The aim of this pilot study is to assess, naturalistically, the effectiveness of deep transcranial magnetic stimulation (DTMS) in a sample of subjects with treatment-resistant depression. To do this, enrolled depressed outpatients will be assigned to receive 4 weeks of daily DTMS and will be evaluated at baseline and during week 5. We hypothesize that treatment with DTMS will be associated with significant clinical improvements in depressive and anxious symptoms, and will be well tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode\n* Baseline score ≥ 15 on the QIDS-C\n* Stable medication regimen (\\> 4 weeks)\n\nExclusion Criteria:\n\n* Psychotic features in the current episode\n* Lifetime history of psychotic disorders and/or bipolar I or II disorders\n* Substance or alcohol abuse/dependence in the past 6 months\n* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)\n* Uncontrolled medical disease (e.g., cardiovascular, renal)\n* Pregnancy and/or lactation\n* Presence of a specific contraindication for DTMS (e.g., personal history of epilepsy, metallic head implant)\n* Hearing loss\n* Personal history of abnormal brain MRI findings"}, 'identificationModule': {'nctId': 'NCT01409304', 'briefTitle': 'Effectiveness of Deep Transcranial Magnetic Stimulation in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Douglas Mental Health University Institute'}, 'officialTitle': 'Effectiveness of Deep Transcranial Magnetic Stimulation for Treating Major Depression: a Pilot Study', 'orgStudyIdInfo': {'id': 'DTMS-ERB10/18-2011'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Deep Transcranial Magnetic Stimulation (DTMS)', 'type': 'DEVICE', 'description': 'DTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4H1R3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Neuromodulation Research Clinic, Douglas Mental Health University Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Marcelo T Berlim, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University & Douglas Mental Health University Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Douglas Mental Health University Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brainsway', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Neuromodulation Research Clinic', 'investigatorFullName': 'MARCELO T. BERLIM', 'investigatorAffiliation': 'Douglas Mental Health University Institute'}}}}