Comparing classic and deep rTMS treatments for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of classic high-frequency repetitive transcranial magnetic stimulation (rTMS) using an 8-shaped coil against deep rTMS using an H-shaped coil for patients with treatment-resistant depressive disorder. Participants will be randomly assigned to one of two treatment arms, receiving a total of 20 rTMS sessions over four weeks, along with standard therapy. Follow-up visits will occur at 30, 60, and 90 days post-treatment to assess outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier Henri Laborit
  Poitiers, France Recruiting

Study contacts

• Principal investigator: Ghina HARIKA-GERMANEAU, Dr — Centre Hospitalier Henri Laborit
• Study coordinator: Ghina HARIKA-GERMANEAU, Dr
• Email: ghina.harika-germaneau@ch-poitiers.fr
• Phone: 0033 5 16 52 61 18

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.