Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 'Hamilton depression rating scale (HDRS)
研究概览
简要总结
number of center : 1
- duration of study : 24 months
- recruitement time : 23 months
- Aim :Principal
Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.
Secondary
Evaluate the impact of rTMS on cognitive functions.
详细描述
The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TRD stage I Thase-Rush
- •HDRS + or = 18
- •Patients age 18 to 70 years.
- •Negative pregnancy test and contraception for women.
- •Informed Consent
排除标准
- •Patient was treated with mood stabilizer in the previous week
- •Other disorder on axis I of the DSM IV than depressive disorder.
- •Patient with an addiction problem other than tobacco and caféine
- •antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
- •Previous history of head trauma the previous two years.
- •intracranial hypertension.
- •not affiliated to the social security Patient
- •patient under constraint hospitalisation
- •Under legal protection measure
结局指标
主要结局
'Hamilton depression rating scale (HDRS)
时间窗: one years
The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD). The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.
次要结局
未报告次要终点
研究者
René BENADHIRA
MD
Centre hospitalier de Ville-Evrard, France