Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision [DSM-IV-TR])
- •Baseline score ≥ 13 on the QIDS-C
- •Stable medication regimen (> 4 weeks)
排除标准
- •Psychotic features in the current episode
- •Lifetime history of psychotic disorders and/or bipolar I or II disorders
- •Substance or alcohol abuse/dependence in the past 6 months
- •Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- •Uncontrolled medical disease (e.g., cardiovascular, renal)
- •Pregnancy and/or lactation
- •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
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
时间窗: week 4
Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5
次要结局
- 21-item Hamilton Depression Rating Scale (HAM-D21)(week 4)
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(week 4)
研究者
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute