Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression (STIMAGNECT)

Centre Hospitalier du Rouvray

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: sham rTMS-ECT; Device: active rTMS-ECT

Study type: Interventional

Funder types: Other

Identifiers

NCT02830399

2015-A01810-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

active rTMS-ECT

Active Comparator group

Description:

5 active high frequency rTMS before 5 bilateral ECT

Treatment:

Device: active rTMS-ECT

sham rTMS-ECT

Placebo Comparator group

Description:

5 sham rTMS before 5 bilateral ECT

Treatment:

Device: sham rTMS-ECT