NCT01849367已完成1 期
Trial of Bilateral tDCS for Depression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Montgomery Asberg Depression Rating Scale for Depression (MADRS)
研究概览
简要总结
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant meets criteria for a DSM-IV Major Depressive episode.
- •MADRS score of 20 or more.
排除标准
- •Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
- •History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
- •Inadequate response to ECT in the current episode of depression.
- •Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
- •Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- •Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
- •Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- •Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
- •Participants who are not fluent in English will not be included in the trial for safety reasons.
结局指标
主要结局
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
时间窗: 4 weeks
次要结局
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)(4 weeks)
研究者
Colleen Loo
Professor
The University of New South Wales
研究点 (2)
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