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Compares treatment options for Depressive Disorder, Treatment-Resistant
Official title Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
ClinicalTrials.gov ID: NCT04956016
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Volunteer people 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
You likely can't join if
- 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...
See the full eligibility criteria
- Volunteer people 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
- 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...
- Pregnancy
- Simultaneous participation to another interventionnal study
The study team makes the final eligibility decision.
Where it's taking place
- Poitiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poitiers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.