Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-01 @ 5:56 PM
Study NCT ID:
NCT04037592
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-28', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in 17-item Hamilton Depression Rating Scale', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)', 'description': 'the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)'}], 'secondaryOutcomes': [{'measure': 'Response rate after 3-week treatment at the end of iTBS sessions and three and six month after.', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)', 'description': 'improvement \\> 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)'}, {'measure': 'Remission rate after 3-week treatment', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation)', 'description': '17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)'}, {'measure': 'Changes in Clinical Global Index', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Clinical Global Index'}, {'measure': 'Changes in depression severity, rated by self-reported', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.'}, {'measure': 'Changes in Young Mania Rating Scale', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.'}, {'measure': 'Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'Maudsley staging method'}, {'measure': 'Baseline brain connectivity and the further antidepressant efficacy of brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'baseline functional MRI'}, {'measure': 'the change of brain connectivity after 3-week iTBS treatment', 'timeFrame': 'Baseline, Week 3', 'description': 'the change in brain connectivity'}, {'measure': 'Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress.'}, {'measure': 'Changes in EEG band before and after brain stimulation', 'timeFrame': 'Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment)', 'description': 'Perform rostral anterior cingulate cortex(rACC)-engaging cognitive task(RECT) before 1-st treatment'}, {'measure': 'Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'baseline single-pulse stimulation'}, {'measure': 'Changes in single-pulse stimulation before and after brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'the change in single-pulse stimulation'}, {'measure': 'Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'baseline paired-pulse stimulation'}, {'measure': 'Changes in paired-pulse stimulation before and after brain stimulation', 'timeFrame': 'Baseline, Week 3', 'description': 'the change in paired-pulse stimulation'}, {'measure': 'Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'the altered anxiosomatic cluster symptoms (range, 0 to 26, with higher scores indicating more severe anxiosomatic symptoms).The anxiosomatic cluster symptoms comprised nine items derived from HDRS-17: early insomnia, middle insomnia, slowness or retardation, psychic anxiety, autonomic anxiety, gastrointestinal symptoms, somatic symptoms, genital symptoms, and hypochondriasis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'referencesModule': {'references': [{'pmid': '36484844', 'type': 'DERIVED', 'citation': 'Cheng CM, Li CT, Jeng JS, Chang WH, Lin WC, Chen MH, Bai YM, Tsai SJ, Su TP. Antidepressant effects of prolonged intermittent theta-burst stimulation monotherapy at the bilateral dorsomedial prefrontal cortex for medication and standard transcranial magnetic stimulation-resistant major depression: a three arm, randomized, double blind, sham-controlled pilot study. Eur Arch Psychiatry Clin Neurosci. 2023 Oct;273(7):1433-1442. doi: 10.1007/s00406-022-01523-4. Epub 2022 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates an association between different dosage and the antidepressant efficacy of theta burst stimulation in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e. standardized dosage intermittent theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment or sham treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 21 to 70 years of age.\n* Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)\n* Participants failed to respond to at least one adequate antidepressant treatment in their current episode\n* Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)\n* Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.\n* Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.\n\nExclusion Criteria:\n\n* a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)\n* Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.\n* Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers\n* Women with breastfeeding or pregnancy\n* Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)'}, 'identificationModule': {'nctId': 'NCT04037592', 'briefTitle': 'Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients and Its Predictors', 'orgStudyIdInfo': {'id': '2018-07-011C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active standardized iTBS-DMPFC', 'description': 'This active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)', 'interventionNames': ['Device: Active standardized iTBS-DMPFC']}, {'type': 'EXPERIMENTAL', 'label': 'Active high-dosage iTBS-DMPFC', 'description': 'This active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC)', 'interventionNames': ['Device: Active high-dosage iTBS-DMPFC']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC', 'description': 'Patients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil', 'interventionNames': ['Device: Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC']}], 'interventions': [{'name': 'Active standardized iTBS-DMPFC', 'type': 'DEVICE', 'description': 'Participants in the standardized dosage(600 pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.', 'armGroupLabels': ['Active standardized iTBS-DMPFC']}, {'name': 'Active high-dosage iTBS-DMPFC', 'type': 'DEVICE', 'description': 'Participants in the standardized dosage(1800pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.', 'armGroupLabels': ['Active high-dosage iTBS-DMPFC']}, {'name': 'Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC', 'type': 'DEVICE', 'description': 'Half of the patients in the sham group received 3-week the same standardized iTBS parameter stimulation (standardized sham-iTBS), and the other half received the same high dosage iTBS parameter stimulation using a sham coil (high dosage sham-rTMS), which also improved the blinding process', 'armGroupLabels': ['Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Psychiatry, Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}