Comparing classic and deep rTMS treatments for depression
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
This study is testing whether a new type of brain stimulation treatment for depression works better than a classic version for people who haven't found relief from other therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Henri Laborit Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT04956016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of recurrent or isolated depressive episodes who have not changed their antidepressant treatment for at least three weeks.
Not a fit: Patients with psychotic features of depression, substance abuse issues, or a high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results for both classic and deep rTMS approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Poitiers
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.