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| Name | Class |
|---|---|
| Federal Ministry of Health, Germany | OTHER_GOV |
| Institute of Clinical Epidemiology and applied Biometry, University Tuebingen, Germany | UNKNOWN |
| Center of Clinical Trials, University Tuebingen, Germany |
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This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined iTBS/cTBS | Active Comparator | Combined theta burst stimulation (TBS) of the left (intermittent TBS, iTBS) and right (continuous TBS, cTBS) dorsolateral prefrontal cortex (dlPFC; F3 and F4 according to EEG10/20 system). Each stimulation session will comprise 2 trains of 600 stimuli each applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s. In the same session, stimulation with cTBS will be applied continuously for 40 s. Intensity of iTBS/cTBS will be standardized at 80 % of the resting motor threshold (rMT). Additionally, patients receive an electrical co-stimulation of the forehead. One electrode is fixed to FZ and the 2nd one is either fixed to the left forehead (iTBS) or the right forehead (cTBS), rectangular aligned to the upper edge of the FZ-electrode with a distance of 0.5 cm. Intensity of the co-stimulation is applied with 50% of TBS-intensity. |
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| sham stimulation | Sham Comparator | Setup is identical to combined active iTBS/cTBS but TBS is not actively delivered |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | MagVenture Coil Cool B70 A/P |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of Montgomery-Asberg Depression Rating Scale (MADRS) | MADRS reduction of at least 50% of baseline value after end of treatment period between active combined iTBS / cTBS and the sham condition. (rater questionnaire; MADRS raw score ranges between 0 and 60; the higher the score, the more severe depression) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate after treatment | Montgomery-Asberg Depression Rating Scale (MADRS) \ | 6 weeks |
| Reduction of raw score: Montgomery-Asberg Depression Rating Scale (MADRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Plewnia, Prof., MD | Department of Psychiatry and Psychotherapy, University of Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg | Augsburg | 86156 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34146143 | Derived | Plewnia C, Brendel B, Schwippel T, Nieratschker V, Ethofer T, Kammer T, Padberg F, Martus P, Fallgatter AJ. Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). Eur Arch Psychiatry Clin Neurosci. 2021 Oct;271(7):1231-1243. doi: 10.1007/s00406-021-01280-w. Epub 2021 Jun 19. |
| Label | URL |
|---|---|
| This link is related to the published study protocol | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| University of Ulm | OTHER |
| University of Regensburg | OTHER |
| University of Wuerzburg | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| Department of Psychiatry and Psychotherapy, University Leipzig, Germany | UNKNOWN |
| Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Germany | UNKNOWN |
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The usage of a special active/placebo (A/P) coil in combination with an electrical co-stimulation will guarantee masking.
A hard cover surrounds the A/P coil and for this reason it is not possible to see which side is the active side of the coil. By entering a randomized code into the stimulator, the operator receive information whether the coil is in the correct position or has to be flipped around. The code does not allow third parties to identify to which study arm a patient has been assigned. The concealment of the assignment remains until the statistical analysis is finished.
| Sham Transcranial Magnetic Stimulation |
| Device |
MagVenture Coil Cool B70 A/P without TMS being actively delivered |
|
The reduction of the raw score after treatment will be compared between active TBS and sham TBS (rater questionnaire; range between 0 and 60; higher score indicates higher level of severity) |
| 6 weeks |
| Reduction of raw score: Hamilton Depression Rating Scale 17 items (HDRS17) | The reduction of the raw score after treatment will be compared between active TBS and sham TBS (rater questionnaire; score ranges from 0-53;higher score indicates higher level of severity) | 6 weeks |
| Reduction of raw score: Clinical Global Impression (CGI) | The reduction of the raw score after treatment will be compared between active TBS and sham TBS (rater questionnaire; score ranges from 0-7; higher score indicates higher level of severity) | 6 weeks |
| Reduction of raw score: Beck Depression Inventory (BDI-II) | The reduction of the raw score during follow-up will be compared between active TBS and sham TBS (self-rating questionnaire; score ranges from 0-63; higher score indicates higher level of severity) | 10 and 18 weeks |
| Reduction of raw score: WHO-5 well-being index | The reduction of the raw score during follow-up will be compared between active TBS and sham TBS (self-rating questionnaire; score ranges from 0-25; lower score indicates higher level of severity) | 10 and 18 weeks |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | Functionality will be assessed by Work Productivity and Activity Impairment Questionnaire (WPAI; self-rating questionnaire) at baseline, after treatment period as well as during follow-up; contains 6 questions about the effect of health problems on the ability to work and perform regular activities. Health problems are defined as any physical or emotional problem or symptom. Patients are asked to fill in the blanks or circle a number; there is no overall score; | 6 and 18 weeks |
| Frequency of adverse events | Comparison of both arms in respect to number of adverse events during treatment period | 6 weeks |
| Deterioration rate after treatment period | Deterioration is defined as an increase of MADRS (Montgomery-Asberg Depression Rating Scale) score of 25% compared to baseline score (rater questionnaire; range between 0 and 60; higher score indicates higher level of severity) | 6 weeks |
| Examination of the influence of Childhood Trauma Questionnaire (CTQ) at baseline as possible predictor for change of MADRS | It will be examined whether the CTQ can be used for predicting treatment effect, measured by Montgomery-Asberg Depression Rating Scale (MADRS, see above) | 6 weeks |
| Examination of the influence of cognitive performance at baseline as possible predictor for change of MADRS | It will be examined whether cognitive performance measured by THINC-Integrated Tool (Thinc-it -tool; includes 4 different test covering different aspects of cognition) at baseline can be used for predicting treatment effect, measured by Montgomery-Asberg Depression Rating Scale (MADRS, see above) | 6 weeks |
| University of Leipzig, Dept. Psychiatry and Psychotherapy | Leipzig | Germany |
| University of Munich | Munich | 80336 | Germany |
| University of Regensburg, Dept. Psychiatry and Psychotherapy | Regensburg | 93053 | Germany |
| University of Tuebingen, Dept Psychiatry and Psychotherapy | Tübingen | 72076 | Germany |
| University of Um, Dept. Psychiatry and Psychotherapy | Ulm | 89075 | Germany |
| University of Wuerzburg, Dept. Psychiatry and Psychotherapy | Würzburg | Germany |