Using rTMS to treat resistant depression
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
This study is trying out a new treatment called rTMS to see if it can help people with tough-to-treat depression feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de Ville-Evrard, France Academic / other |
| Locations | 2 sites (Neuilly sur Marne and 1 other locations) |
| Trial ID | NCT04354935 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) in treating patients with resistant depression. It aims to assess the treatment's impact on depression symptoms, quality of life, and the correlation between personality dimensions and depression. The study will measure changes in the Hamilton Depression Rating Scale (HDRS-17) scores from baseline to the end of the initial treatment period, which lasts between 1 and 6 weeks. Additionally, it will evaluate the treatment's tolerance and the rates of response and remission among participants.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing a depressive episode that is resistant to at least two different antidepressants.
Not a fit: Patients with contraindications to TMS, such as unstable epilepsy or those who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from resistant depression.
How similar studies have performed: Previous studies have shown promising results with rTMS in treating depression, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presenting a depressive episode characterized as resistant according to the DSM 5 criteria * resistance is characterized by: non-response to at least two different antidepressants prescribed at effective doses for a duration greater than or equal to 6 weeks. * Patient who agrees to participate in the study and who has signed an informed consent. * Patient fluent in French * Affiliation to a social security scheme. * Women of childbearing age must be on contraception Exclusion Criteria: * Presenting a contraindication to TMS: intrafemale foreign body cranial, unstable epilepsy, cochlear implant, pacemaker, pregnancy * Presence of a psychotic disorder * Presence of an unstable medical condition * Presence of schizophrenia or persistent delusional disorder * Persons under guardianship, curatorship and safeguarding of justice. * Pregnant women, * Woman of childbearing age without effective contraception * Breastfeeding woman
Where this trial is running
Neuilly sur Marne and 1 other locations
- Youcef Bencherif — Neuilly sur Marne, France (Recruiting)
- Unité de recherche clinique — Neuilly Sur Marne, Île De France, France (Recruiting)
Study contacts
- Study coordinator: Youcef Bencherif
- Email: youcef.bencherif@gmail.com
- Phone: 0782723674
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.