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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
Centre Esquirol- CHU de Caen
Caen, France
Centre Hospitalier Laborit
Poitiers, France
Centre Hospitalier du Rouvray
Sotteville-lès-Rouen, France
Relative improvement of the Hamilton Rating Scale for Depression 21-items score
Time frame: Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion
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