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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- A 50% change of MADRS score
研究概览
简要总结
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.
20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
classic rTMS treatment
Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy
干预措施: classic rTMS using the 8-shaped coil (Device)
treatment with deep rTMS
Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies
干预措施: deep rTMS using the H1-shaped coil (Device)
结局指标
主要结局
A 50% change of MADRS score
时间窗: Day 60
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score \>34 being severe depression.
次要结局
未报告次要终点