Transcranial Direct Current Stimulation for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy and safety of tDCS
研究概览
简要总结
Several studies have shown that tDCS is valuable and safe options to improve depressive symptoms in adult patients . However, regarding the tDCS to treat depression in elderly population, only few studies have been reported, and there is no consensus among them. To our knowledge, prefrontal cortex tDCS could be reasonably safe and efficient options for the treatment of several psychiatric illnesses in a population presenting resistance to and/or intolerance of pharmacotherapy . Moreover, the safety tolerability profile of tDCS is a strong argument in favour of exploring their use in the depressed population. Therefore, current study will investigate the efficacy and safety of prefrontal tDCS used as additive treatment in patients with LLD.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet the criteria of major depression defined by DSM-5 criteria
- •Participants will be non-responders and taking an antidepressant of adequate dose and for ≥4 weeks in the current episode which has not led to sufficient clinical improvement (defined as a minimum level of 2 on the ATHF); or can't tolerate the adverse effects of antidepressant in the current episode
- •Ambulatory participants with or without any aiding device
排除标准
- •An urgent risk of suicide or severe depression
- •A history of ineffectiveness with tDCS
- •People who are clinically contraindicated to receive tDCS intervention or MRI assessment, such as having any brain lesion, intracranial implants (clips, cochlear implants), a tattoo or metal embedded in their scalp or brain
- •Any instable medical condition
- •A history of epilepsy,
- •A history of substance use (within one year)
- •People with dementia or psychotic disorder.
- •Any condition which would make the subject unsuitable for the study under the physician's assessment.
结局指标
主要结局
Efficacy and safety of tDCS
时间窗: 8 Weeks
\[Primary Outcome Measures\] * Hamilton Depression Rating Scale (HAMD) for depression * Comparison of these changes in both sham and active tDCS groups. * Response was defined as ≥ 50% HAMD score improvement from baseline.
次要结局
未报告次要终点
研究者
Mu-N Liu
Principal Investigator
Taipei Veterans General Hospital, Taiwan