NCT01974076Unknown不适用
A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 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
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.
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, Investigator)
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
- •Participants will be ≥ 18 years old.
- •Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
- •MADRS score ≥ 20 at study entry.
排除标准
- •Participant is unable to give informed consent.
- •DSM-IV diagnosis of psychotic disorder (lifetime).
- •Bipolar disorder diagnosis and not on a mood stabiliser.
- •Eating disorder (current or within past year).
- •Obsessive compulsive disorder (lifetime).
- •Post-traumatic stress disorder (current or within past year).
- •Mental retardation.
- •Drug or alcohol abuse or dependence (preceding 3 months).
- •Inadequate response to ECT (current episode of depression).
- •Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
- •Clinically defined neurological disorder or insult.
- •Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- •Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
- •Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
- •Participant becomes hypomanic or manic, as defined by DSM-IV.
结局指标
主要结局
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
时间窗: 3 weeks
次要结局
- Depression and Anxiety Stress Scale(3 weeks)
研究者
Colleen Loo
Professor
The University of New South Wales
研究点 (2)
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