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This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment | Experimental | 600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks) |
|
| active treatment 2 | Active Comparator | 600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittend theta burst stimulation | Device | intermittend theta burst stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| relapse (number of patients who have a relapse for depression) | 50% increase of symptoms according to Hamilton depression rating scale | 33 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome) | 49 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Schecklmann, Prof. | Contact | +49-941-941-2054 | martin.schecklmann@medbo.de | |
| Mohamed Abdelnaim, Dr. | Contact | +49-941-941-1256 | mohamed.abdelnaim@medbo.de |
| 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, University of Regensburg | Recruiting | Regensburg | 93055 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 49 weeks |
| World Health Organisation quality of life bref | World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome) | 49 weeks |
| clinical global impression | clinical global impression (range: 0-7; higher values = worse outcome) | 49 weeks |
| Columbia-Suicide Severity Rating Scale | Columbia-Suicide Severity Rating Scale (range: 0-6; higher values = worse outcome) | 49 weeks |
| Beck Anxiety Index | Beck Anxiety Index (range: 0-63; higher values = worse outcome) | 49 weeks |
| Global Assessment of Functioning | Global Assessment of Functioning (range: 0-100; lower values = worse outcome) | 49 weeks |