RecruitingNot ApplicableNCT04956016

Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression

Sponsor

Centre Hospitalier Henri Laborit

Enrollment

152 participants

Start Date

Aug 23, 2021

Study Type

INTERVENTIONAL

Conditions

Depressive Disorder, Treatment-Resistant

Summary

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies. 20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Volunteer subjects over 18 years old
Having signed a free and informed consent
Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
Having an antidepressant treatment not modified since 3 weeks
Score to MADRS scale ≥ 21
Subject affiliated to a social security regimen

Exclusion Criteria8

Depression with psychotic caracteristics
Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
Patient hospitalized under duress or under legal protection (guardianship, curatorship)
Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization.
Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
Pregnancy
Simultaneous participation to another interventionnal study