Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Montgomery and Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Participants are aged 18-65 years.
- •Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
- •MADRS score of 20 or more.
- •Right handed
- •A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.
排除标准
- •DSM-V psychotic disorder.
- •Drug or alcohol abuse or dependence (preceding 6 months).
- •Inadequate response to ECT (current episode of depression).
- •Regular benzodiazepine medication
- •Rapid clinical response required, e.g., due to high suicide risk.
- •Clinically defined neurological disorder or insult.
- •Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
研究组 & 干预措施
tDCS + CT
干预措施: Transcranial direct current stimulation combined with cognitive training (Other)
结局指标
主要结局
Montgomery and Asberg Depression Rating Scale (MADRS)
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Melissa Pigot
Research assistant
The University of New South Wales