Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-25 @ 12:33 PM
Study NCT ID:
NCT07026461
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in the MADRS-S score', 'timeFrame': '6 weeks', 'description': 'reduction in the MADRS-S score from baseline to the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Stimulation site pain', 'timeFrame': '15 minutes', 'description': 'Stimulation site pain (self-rated by patients using Numerical Rating Scales (NRS)).'}, {'measure': 'CGI-I', 'timeFrame': '6 weeks', 'description': 'Professionally determined response according to Clinical Global Impression Scale-Improvement (CGI-I)'}, {'measure': 'Patient rate remission', 'timeFrame': '6 weeks', 'description': 'Remission (score \\< 11 on the MADRS-S)'}, {'measure': 'Patient rated response', 'timeFrame': '6 weeks', 'description': 'Response to treatment (a decrease of 50% on MADRS-S)'}, {'measure': 'Self-rated EQ-5D-VAS', 'timeFrame': '6 weeks', 'description': 'Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS)'}, {'measure': 'Drop-out', 'timeFrame': '6 weeks', 'description': 'Drop-out from treatment for any reason within 30 sessions'}, {'measure': 'Adverse events', 'timeFrame': '6 weeks, follow-up at 6 months', 'description': 'Adverse events including severe adverse events'}, {'measure': 'Self-rated EQ-5D-VAS at 6-month follow-up', 'timeFrame': '6 months', 'description': 'Self-rated global health measured with the EQ-5D-VAS at 6-month follow-up'}, {'measure': 'Self rated remission at 6-month follow-up', 'timeFrame': '6 months', 'description': 'Self rated remission (score \\< 11 on MADRS-S) at 6-month follow-up'}, {'measure': 'Hospital admission', 'timeFrame': '6 months', 'description': 'Hospital admissions for depression, hypomanic/manic switch, suicide attempts, and deaths including completed suicides within 6 months after randomization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rtms', 'itbs', 'repetitive transcranial magnetic stimulation', 'randomized controlled trial', 'intermittent theta-burst stimulation'], 'conditions': ['Depression - Major Depressive Disorder', 'Depression Bipolar']}, 'descriptionModule': {'briefSummary': 'Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.\n\nDesign: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.\n\nPrimary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.\n\nSecondary objectives: Include testing for differences in:\n\n* Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).\n* Response to treatment (a decrease of 50% on MADRS-S)\n* Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).\n* Drop-out from treatment.\n* Stimulation site pain measured with the Numerical Rating Scales (NRS).\n* Adverse events.\n* Admission and suicides within 6 months.\n* New treatment course of rTMS or ECT within 6 months\n* Remission (score \\< 11 on the MADRS-S)\n* Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).\n\nStudy population: Patients with unipolar or bipolar depression. Sample size: 350 patients.\n\nInclusion criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.\n\nInclusion time: 2025-07-01 to 2029-01-01'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age at the time of inclusion.\n* A clinical diagnosis of unipolar or bipolar depression according to ICD-10.\n* Acceptance of rTMS.\n* A Swedish personal identity number.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n• If the investigator judges one of the two treatment protocols inappropriate for the patient.'}, 'identificationModule': {'nctId': 'NCT07026461', 'briefTitle': 'Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial', 'orgStudyIdInfo': {'id': '3.1'}, 'secondaryIdInfos': [{'id': 'CIV-ID 23-06-043272', 'type': 'OTHER', 'domain': 'Swedish Medical Product Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'right-sided rTMS', 'description': 'right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'left-sided iTBS', 'description': 'left-sided intermittent theta burst stimulation', 'interventionNames': ['Device: intermittent theta burst stimulation']}], 'interventions': [{'name': 'repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'otherNames': ['rTMS'], 'description': 'Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells.', 'armGroupLabels': ['right-sided rTMS']}, {'name': 'intermittent theta burst stimulation', 'type': 'DEVICE', 'description': 'Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC)', 'armGroupLabels': ['left-sided iTBS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Unit for Brainstimulation', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Robert Bodén, MD, PhD', 'role': 'CONTACT', 'email': 'robert.boden@uu.se', 'phone': '+46186110000'}, {'name': 'Robert Bodén, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unit for Brainstimulation', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Axel Nordenskjöld, MD,PhD', 'role': 'CONTACT', 'email': 'axel.nordenskjold@regionorebrolan.se', 'phone': '+46196021000'}, {'name': 'Cecilia Vestlund, MD', 'role': 'CONTACT', 'email': 'cecilia.vestlund@regionorebrolan.se', 'phone': '+46196021000'}], 'overallOfficials': [{'name': 'Axel Nordenskjöld, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Region Örebro County, Örebro University'}, {'name': 'Robert Bodén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University, Region Uppsala County'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available from the corresponding author upon reasonabe request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala County Council, Sweden', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}