Actively Recruiting
Open-label Randomized Comparative Study of Classic High-frequency rTMS Versus Deep rTMS Treatment in Managing Resistant Depression
Led by Centre Hospitalier Henri Laborit · Updated on 2026-01-13
152
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two different types of repetitive transcranial magnetic stimulation (rTMS) treatments to manage treatment-resistant depressive disorder. The study aims to show whether deep rTMS, using an H1-shaped coil, is more efficient than classic high-frequency rTMS with a conventional 8-shaped coil. Participants are adults diagnosed with recurrent or isolated depressive episodes according to DSM IV criteria and who have not changed their antidepressant treatment for at least three weeks. Participants will be randomly assigned to one of two treatment groups. One group will receive classic rTMS with the 8-shaped coil combined with standard therapy, while the other group will receive deep rTMS using the H1-shaped coil and standard therapies. Both groups will undergo 20 rTMS sessions scheduled as five sessions per week. Following treatment, there are three follow-up visits planned at 30, 60, and 90 days. During the study, participants will be monitored for changes in their depression symptoms, primarily measured by the Montgomery and Åsberg Depression Rating Scale (MADRS) at Day 60, focusing on a 50% improvement in score. Regular assessments and follow-ups will allow researchers to compare the effects of the two rTMS methods. The total duration of participation includes treatment sessions and follow-up visits over approximately three months.
CONDITIONS
Brief Title
Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer subjects over 18 years old
- Signed free and informed consent
- Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria
- Stable antidepressant treatment for at least 3 weeks
- Montgomery and Åsberg Depression Rating Scale (MADRS) score of 21 or higher
- Affiliated with a social security regimen
You will not qualify if you...
- Depression with psychotic characteristics
- Co-morbid diagnosis of schizophrenia or substance dependence/abuse according to DSM IV
- Previous electroconvulsive therapy for current episode with no response
- Hospitalized under duress or under legal protection
- High suicide risk (MADRS item 10 score greater than 4) without hospitalization
- Contraindications for MRI or rTMS such as history of seizures, neurological or neurosurgical disorders, metallic implants or devices
- Pregnancy
- Participation in another interventional study at the same time
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive 20 sessions of rTMS treatment using either the classic 8-shaped coil or the deep H1-shaped coil, with sessions occurring 5 times per week.
20 treatment sessions (in-person, 5 sessions per week)
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Henri Laborit
Poitiers, France
Actively Recruiting
Research Team
G
Ghina HARIKA-GERMANEAU, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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