NCT01562184已完成2 期
A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 12
- 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. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or above.
- •Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
- •Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
排除标准
- •Current episode duration greater than 3 years.
- •Failed more than 3 adequate antidepressant trials in current episode.
- •DSM-IV psychotic disorder.
- •Drug or alcohol abuse or dependence (preceding 3 months).
- •Inadequate response to ECT in the current episode of depression.
- •Rapid clinical response required, e.g., high suicide risk.
- •Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
- •Clinically defined neurological disorder or insult.
- •Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- •Pregnancy.
- •Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
结局指标
主要结局
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
时间窗: 12 weeks
次要结局
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)(12 weeks)
- Montreal Cognitive Assessment (MoCA): Global Cognitive Function(8 weeks)
研究者
Colleen Loo
Professor
The University of New South Wales
研究点 (12)
Loading locations...
相似试验
已完成
1 期
Trial of Bilateral tDCS for DepressionDepressionNCT01849367The University of New South Wales4
Unknown
1 期
Depression and Transcranial Direct Current Stimulation (tDCS)DepressionNCT00256438The University of New South Wales20
招募中
不适用
Transcranial Direct Current Stimulation for DepressionDepressive DisorderNCT06187454Taipei Veterans General Hospital, Taiwan30
已完成
2 期
Transcranial Direct Current Stimulation to Treat Major Depressive DisorderMajor Depressive DisorderNCT01149889University of Sao Paulo60
已完成
不适用
Transcranial Direct Current Stimulation (tDCS) As Treatment for Major DepressionUnipolar DepressionMajor Depressive DisorderDepressionNCT02530164Ludwig-Maximilians - University of Munich163