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This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function, and peripheral biomarkers in MDD patients.
This is a sham-controlled, randomized trial for patients with MDD to identify the effects of TBS on depressive symptomatology, brain function (e.g. functional MRI, PET, and qEEG), peripheral biomarkers (e.g. candidate genetic expression, neuroendocrine, inflammation, and neurotransmissions) in MDD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta-burst stimulation (TBS) | Experimental | Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) |
|
| Sham controlled intervention | Sham Comparator | The sham-TBS coil produced a similar sound without a magnetic pulse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBS | Device | Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAMD) | The Hamilton Depression scale sum score (HAMD21)
| From Weeks 0 to 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | The decreasing level of the Hamilton Rating Scale for Depression from 0% to 50% compared to the sham group. | From Weeks 0 to 24 |
| Remission rate | The higher scores on the Hamilton Rating Scale for Depression down to 8 points would be considered remission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuan-Pin Su, MD PhD | China Medical University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Sham | Device | The sham-TBS coil produced a similar sound without a magnetic pulse. |
|
| From Weeks 0 to 24 |