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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active standardized iTBS-DMPFC | Experimental | This active group will receive standardized dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC) |
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| Active high-dosage iTBS-DMPFC | Experimental | This active group will receive high dosage of intermittent theta-burst on dorsomedial prefrontal cortex(DMPFC) |
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| Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC | Sham Comparator | Patients in the sham group will receive the same standardized or high-dosage iTBS performing by a sham coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active standardized iTBS-DMPFC | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in 17-item Hamilton Depression Rating Scale | the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression) | Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after 3-week treatment at the end of iTBS sessions and three and six month after. | improvement > 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression) | Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36484844 | Derived | 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. |
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| Active high-dosage iTBS-DMPFC | Device | 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. |
|
| Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC | Device | 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 |
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| Remission rate after 3-week treatment | 17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression) | Baseline, Week 1, Week 2, Week 3, Week 15(three-month after brain stimulation), Week 27(Six-month after brain stimulation) |
| Changes in Clinical Global Index | Clinical Global Index | Baseline, Week 1, Week 2, Week 3 |
| Changes in depression severity, rated by self-reported | Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom. | Baseline, Week 1, Week 2, Week 3 |
| Changes in Young Mania Rating Scale | Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms. | Baseline, Week 1, Week 2, Week 3 |
| Baseline treatment refractory level and the further antidepressant efficacy of brain stimulation | Maudsley staging method | Baseline, Week 3 |
| Baseline brain connectivity and the further antidepressant efficacy of brain stimulation | baseline functional MRI | Baseline, Week 3 |
| the change of brain connectivity after 3-week iTBS treatment | the change in brain connectivity | Baseline, Week 3 |
| Baseline Life event stress scale and the further antidepressant efficacy of brain stimulation | Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress. | Baseline, Week 3 |
| Changes in EEG band before and after brain stimulation | Perform rostral anterior cingulate cortex(rACC)-engaging cognitive task(RECT) before 1-st treatment | Day 1(pre-RECT, post RECT, post 1st treatment, pre-30th treatment) |
| Baseline single-pulse stimulation and the further antidepressant efficacy of brain stimulation | baseline single-pulse stimulation | Baseline, Week 3 |
| Changes in single-pulse stimulation before and after brain stimulation | the change in single-pulse stimulation | Baseline, Week 3 |
| Baseline paired-pulse stimulation and the further antidepressant efficacy of brain stimulation | baseline paired-pulse stimulation | Baseline, Week 3 |
| Changes in paired-pulse stimulation before and after brain stimulation | the change in paired-pulse stimulation | Baseline, Week 3 |
| Change in anxiosomatic cluster symptoms derived 17-item Hamilton Depression Rating Scale | 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. | Baseline, Week 1, Week 2, Week 3 |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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