Depressive Disorder, Treatment-Resistant
Conditions
Brief 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.
Interventions
DEVICEclassic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week)
DEVICEdeep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)
Sponsors
Centre Hospitalier Henri Laborit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A 50% change of MADRS score | Day 60 | The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score \>34 being severe depression. |
Countries
France
Contacts
Primary ContactGhina HARIKA-GERMANEAU, Dr
Outcome results
None listed