tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
研究概览
简要总结
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.
Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.
详细描述
In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 ans
- •Remission (MADRS <10) of a major depressive episode after acute treatment with ECT + venlafaxine
- •Lithium adjunction 48h after the last ECT session
- •No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance.
- •Capacity to consent
- •Sufficient comprehension of the French language
排除标准
- •Contra-indications to tDCS
- •Neurologic conditions
- •Severe medical conditions.
- •Pregnancy/breast-feeding.
- •Current use of benzodiazepines or antipsychotics
研究组 & 干预措施
tDCS
The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
干预措施: Device : Transcranial direct current stimulation (Device)
Sham tDCS
The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
干预措施: Device : sham Transcranial direct current stimulation (Device)
结局指标
主要结局
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
时间窗: 6 months
MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months).
次要结局
- Time to relapse(during 6 months)
- Montreal Cognitive Assesment (MoCA)(basal and at 6 months)
- Scores on Clinical Global Impression (CGI)(after remission basal and at 6 months)