Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Change from baseline in Montgomery-Åsberg depression scale (MADRS)
研究概览
简要总结
The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.
This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.
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
- •Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33)
- •Able to understand the purpose and potential risks of the study
- •Able to sign informed consent
排除标准
- •intracranial metal implants or other foreign intracranial metal object
- •history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc.
- •schizophrenia
- •bipolar disorder
- •psychotic disorder
- •substance abuse or dependency
- •contra-indications to tDCS
- •personality disorder that may prevent him/her to commit to the study
- •skin lesion in the area of stimulation
- •planned treatment of current depressive episode with ECT or rTMS
研究组 & 干预措施
Device: Sooma tDCS
The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6.
干预措施: Sooma tDCS (Device)
Device: Sham tDCS
The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change from baseline in Montgomery-Åsberg depression scale (MADRS)
时间窗: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Efficacy
次要结局
- Change from baseline in Beck Depression Inventory (BDI) scale.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)
- Dichotomised response measured with MADRS.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)
- Dichotomised remission measured with MADRS.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)