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This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS-DLPFC | Experimental | This active group will receive high-frequency repetitive TMS stimulation. |
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| Active iTBS-DLPFC | Experimental | This active group will receive intermittent theta-burst TMS stimulation. |
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| Sham TBS-DLPFC or Sham rTMS-DLPFC | Sham Comparator | Patients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS-DLPFC | Device | Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC 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 4(day 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate after 4-week treatment at the end of TMS sessions and three 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 4, week 16 (day 80) |
| Remission rate after 4-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Ta Li, Professor | Contact | 886 -2- 28757027 | 298 | ctli2@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Active iTBS-DLPFC | Device | Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator. |
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| Sham TBS-DLPFC or Sham rTMS-DLPFC | Device | Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process. |
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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 4, week 16 (day 80) |
| Changes in Clinical Global Index | Clinical Global Index | Baseline, Week 1, Week 2, Week 3, Week 4(day 20) |
| 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, Week 4(day 20) |
| 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, Week 4(day 20) |
| The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation | Val/Val, Met/Met, Val/Met genotype and the efficacy after receiving 4-week treatment. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale | Baseline, Week 4(day 20) |
| The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation | baseline PET/MRI.The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale. | Baseline, Week 4(day 20) |
| The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation | Maudsley staging method. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale. | Baseline, Week 4(day 20) |
| The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation | Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale. | Baseline, Week 4(day 20) |
| Changes in EEG band before and after brain stimulation | Perform rACC-engaging cognitive task(RECT) before 1-st treatment | Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment) |