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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
| Centre Hospitalier Henri Laborit | OTHER |
| University Hospital, Caen | OTHER |
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It's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (TRD). The main objective of this study was to evaluate the efficacy of priming repeated Transcranial Magnetic Stimulation (rTMS) sessions before Electroconvulsive therapy (ECT) for treatment of TRD patients. The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.
Included patients are adults, aged between 18 and 70 years, with major depression (Hamilton Rating scale for Depression, HAMD ≥ 15). Patients don't have any experience concerning repeated Transcranial Magnetic Stimulation (rTMS).
Patients with treatment-resistant depression (TRD) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rTMS before Electroconvulsive therapy (ECT) and the other one received sham-rTMS before ECT. The depressive symptoms and the cognitive functions are evaluated before rTMS, after 5 rTMS and after 5 ECT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active rTMS-ECT | Active Comparator | 5 active high frequency rTMS before 5 bilateral ECT |
|
| sham rTMS-ECT | Placebo Comparator | 5 sham rTMS before 5 bilateral ECT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active rTMS-ECT | Device | 5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative improvement of the Hamilton Rating Scale for Depression 21-items score | Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Esquirol- CHU de Caen | Caen | 14000 | France | |||
| Centre Hospitalier Laborit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34579796 | Derived | Rotharmel M, Quesada P, Husson T, Harika-Germaneau G, Nathou C, Guehl J, Dalmont M, Opolczynski G, Mirea-Grivel I, Millet B, Gerardin E, Compere V, Dollfus S, Jaafari N, Benichou J, Thill C, Guillin O, Moulier V. The priming effect of repetitive transcranial magnetic stimulation on clinical response to electroconvulsive therapy in treatment-resistant depression: a randomized, double-blind, sham-controlled study. Psychol Med. 2023 Apr;53(5):2060-2071. doi: 10.1017/S0033291721003810. Epub 2021 Sep 28. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| sham rTMS-ECT | Device | 5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT |
|
| Poitiers |
| 86000 |
| France |
| Centre Hospitalier du Rouvray | Sotteville-lès-Rouen | 76300 | France |