Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05390593
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-05-20', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 17-item Hamilton Depression Rating Scale', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': '17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression)'}, {'measure': 'Change in Montgomery-Asberg Depression Rating Scale', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': 'Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression)'}, {'measure': 'Change in Beck Anxiety Inventory', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': 'Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey)'}], 'secondaryOutcomes': [{'measure': 'Response rate after 2-week treatment at the end of iTBS (HDRD-17 )', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': 'Improvement \\> 50 % of HDRD-17'}, {'measure': 'Response rate after 2-week treatment at the end of iTBS (MADRS)', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': 'Improvement \\> 50 % of MADRS'}, {'measure': 'Changes in Clinical Global Index Severity', 'timeFrame': 'Baseline, Week 1, Week 2, Week 4', 'description': 'Clinical Global Index'}, {'measure': 'Changes in Heart Rate Variability (HRV) band', 'timeFrame': 'Baseline, Week 1, Day 3, Week 2, Week 4', 'description': 'Heart rate variability measured by Wegene 8Z11'}, {'measure': 'Changes in EEG band', 'timeFrame': 'Baseline, Week 1, Day 3, Week 2, Week 4', 'description': 'Changes in EEG band before and after brain stimulation. Subject EEG activity including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.'}, {'measure': 'Change in BDNF', 'timeFrame': 'Baseline, Week 2', 'description': 'Changes in BDNF values'}, {'measure': 'Change in TSH', 'timeFrame': 'Baseline, Week 2', 'description': 'Change in TSH values'}, {'measure': 'Change in T3', 'timeFrame': 'Baseline, Week 2', 'description': 'Change in T3'}, {'measure': 'Change in T4', 'timeFrame': 'Baseline, Week 2', 'description': 'Change in T4'}, {'measure': 'Change in cortisol', 'timeFrame': 'Baseline, Week 2', 'description': 'Change in cortisol'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Repetitive transcranial magnetic stimulation', 'Mood Disorders'], 'conditions': ['Depressive Disorder, Treatment-Resistant']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The diagnosis of major depressive disorder according to DSM-5\n2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.\n3. Before treatment, patient have to stop antidepressant for at least 1 weeks.\n4. Capable and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Have a concomitant major, unstable medical or neurologic illness :\n\n * Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.\n * Severe brian disease: Brain tumor, encephalitis, brian injury.\n2. Intracranial implant and other ferromagnetic materials close to the head.\n3. History of Seizures.\n4. Cardiac pacemaker.\n5. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05390593', 'acronym': 'iTBS', 'briefTitle': 'Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis', 'orgStudyIdInfo': {'id': 'CMRPG8L0871'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTBS-1800', 'description': 'The active group will receive 1800 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.', 'interventionNames': ['Device: iTBS-1800']}, {'type': 'EXPERIMENTAL', 'label': 'iTBS-1200', 'description': 'The active group will receive 1200 pluse of intermittent theta-bursts in the left dorsolateral prefrontal cortex.', 'interventionNames': ['Device: iTBS-1200']}], 'interventions': [{'name': 'iTBS-1800', 'type': 'DEVICE', 'description': 'Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \\& More stimulator.', 'armGroupLabels': ['iTBS-1800']}, {'name': 'iTBS-1200', 'type': 'DEVICE', 'description': 'Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG \\& More stimulator.', 'armGroupLabels': ['iTBS-1200']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'ChangGungMH', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatry Department', 'investigatorFullName': 'Chih-Wei Hsu', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}