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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial on Efficacy of Repeated Transcranial Magnetic Stimulation (rTMS) to Improve Electroconvulsive Therapy (ECT) in Treatment-Resistant Depression (TRD): STIMAGNECT Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: active rTMS-ECT
* Device: sham rTMS-ECT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active rTMS-ECT<br>5 active high frequency rTMS before 5 bilateral ECT | Device: active rTMS-ECT<br>* 5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT<br>|
| Placebo Comparator: sham rTMS-ECT<br>5 sham rTMS before 5 bilateral ECT | Device: sham rTMS-ECT<br>* 5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment-resistant-depression, rTMS, ECT, Augmentation strategy