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Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.
This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bilateral theta burst stimulation to the DLPFC | Experimental | intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC |
|
| Sham stimulation | Placebo Comparator | Sham stimulation with a 45° tilted coil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS) | Device | intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responders (response = decrease of the Montgomery-Ã…sberg Depression Rating Scale for at least 50%) | after the end of treatment (week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Hamilton rating scale for depression (HAMD 17) | baseline, after the end of treatment (week 6) | |
| Change of the Beck Depression Inventory (BDI) | baseline, after the end of treatment (week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tübingen, Department of Psychiatry and Psychotherapy | Tübingen | Germany |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Change of the Montgomery-Asberg rating scale for depression (MADRS) score | baseline, after the end of treatment (week 6) |
| D001519 |
| Behavior |