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Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.
Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.
In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thetaburst Stimulation | Experimental | 1: Thetaburst stimulation: right DLPFC continuous TBS followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 stimuli, 80% motorthreshold |
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| High frequency rTMS | Experimental | 2: Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC, 110% motor threshold, followed by 1000 stimuli of 10 Hz over the left DLPFC , 110% motorthreshold |
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| Placebo Stimulation | Experimental | 3: Sham Stimulation (Sham coil): right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thetaburst Stimulation | Device | Thetaburst stimulation: continuous TBS over the right DLPFC, followed by intermitted TBS over the left DLPFC, each with 50 Hz, together 1200 stimuli (80% motorthreshold) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) | 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Beck Depression Inventar, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, the Alertness (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75) | 75 days | |
| Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth, MD | University of Regensburg- Dept. of Psychiatry | Principal Investigator |
| Michael Landgrebe, MD | University of Regensburg, Dept. of Psychiatry | Principal Investigator |
| Julia Burger, MD | University of Regensburg- Dept. of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg- Dept of Psychiatry | Regensburg | Bavaria | 93053 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| High frequency rTMS | Device | Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC (110% motor threshold)followed by 1000 stimuli of 10 Hz over the left DLPFC (110% motorthreshold) |
|
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| Placebo Stimulation | Device | Sham Stimulation (Sham coil):right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold |
|
|
| 75 days |