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This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS).
This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks).
The patients to be treated are those who refuse treatment with antidepressant medications.
The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks.
A interim analysis is planned after 36 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment | Experimental | intermittent theta burst stimulation |
|
| waiting list | No Intervention | patients waiting for intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittend theta burst stimulation (iTBS) | Device | 600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 20 weeks |
| Major Depression Inventory | Major Depression Inventory (range: 0-50; higher values = worse outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth, Prof. | University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy | Regensburg | 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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|
| 20 weeks |
| World Health Organisation quality of life bref | World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome) | 20 weeks |
| State Trait Anxiety Inventory | State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome) | 20 weeks |
| clinical global impression | clinical global impression (range: 0-7; higher values = worse outcome) | 20 weeks |