Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of correct responses at a facial expression recognition task
研究概览
简要总结
Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.
详细描述
Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.
A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.
The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.
Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy controls:
- •Age between 18 and 65 years
- •Given consent.
- •Depressed subjects:
- •Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
- •Age from 18-65
- •Antidepressant stable for the last 4 weeks
- •Given consent
排除标准
- •Healthy controls:
- •Psychiatric disorder
- •Addiction except for tobacco addiction
- •Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- •Neuroleptic or anticonvulsivant treatment
- •Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
- •Depressed subjects:
- •Other psychiatric disorder except for personality disorders
- •Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- •Neuroleptic or anticonvulsivant treatment
- •Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
结局指标
主要结局
Number of correct responses at a facial expression recognition task
时间窗: within 5 days after stimulation
A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard. Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded
次要结局
- Evolution of the depressive symptoms measured by MADRS(an average of two weeks)
- Skin conductance measured in speed per microseconds(within 5 days after stimulation)
- Heart rate measured in number of heart pulses per milliseconds(within 5 days after stimulation)
- Respiratory frequency measured in number of respiratory cycles per minute(within 5 days after stimulation)
- Beck depression inventory scale(within 5 days after stimulation)
- Eye movements during facial emotion recognition task and attentional task(within 5 days after stimulation)
- Performance on an attentional dot-probe task(within 5 days after stimulation)
- tests of executive functions(an average of two weeks)
- Clinical global impression scale(an average of two weeks)