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The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones with active rTMS or iTBS and 2 controls with sham-placebo rTMS or iTBS stimaltions).
The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones and 2 controls):
The following are the inclusion and exclusion criteria for the recruitment process:
The following stimulation protocols will be used to conduct research into the treatment of depressive disorders:
Stimulation with rTMS within the left hemisphere, in the dorsolateral prefrontal cortex, DLPFC (Dorsolateral prefrontal cortex). In the field of stimulation, a protocol based on FDA recommendations, so- called train stimulation (stimulation of a given frequency for a short period of time with longer breaks without stimulation) assuming the following stimulation parameters:
iTBS protocol in the left cerebral hemisphere, in the dorsolateral prefrontal cortex, DLPFC (Dorsolateral prefrontal cortex). Expected range of parameters:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS active | Active Comparator |
| |
| rTMS sham | Sham Comparator |
| |
| iTBS active | Experimental |
| |
| iTBS sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | rTMS (30sessions) or iTBS (40sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale | Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | END of stimulation |
| Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in MADRS scale | Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | 3 months after end of stimulation |
| Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in HAMD scale | Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression. | END of stimulation |
| Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in HAMD scale | Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression. | 3 months after end of stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical Univeristy, Department of Psychiatry | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
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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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| Comparison of efficiency of rTMS active and rTMS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale |
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. |
| END of stimulation |
| Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS | Comparison of efficiency of iTBS active and iTBS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. | 3 months after end of stimulation |