Clinical trial NCT02830399: Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression
Official title: Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: treatment-resistant-depression
rTMS
ECT
Augmentation strategy
Lead sponsor: Centre Hospitalier du Rouvray
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Rouen
name: Centre Hospitalier Henri Laborit
name: University Hospital, Caen
First posted: 2016-07-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Major Depressive Disorder (HAMD≥15)
* Level of resistance ≥ 3 (Thase and Rush)
* Participants who gave their informed, written consent

Exclusion Criteria:

* Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
* History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition
* Pregnancy

Primary outcomes:
measure: Relative improvement of the Hamilton Rating Scale for Depression 21-items score
timeFrame: Relative improvement of the Hamilton Rating Scale for Depression score between the inclusion and 19 days after the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Esquirol- CHU de Caen
city: Poitiers
country: France
facility: Centre Hospitalier Laborit
city: Sotteville-lès-Rouen
country: France
facility: Centre Hospitalier du Rouvray
Study officials:
References:
citation: 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.