临床试验/NCT01792414

NCT01792414已完成不适用

Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

The University of New South Wales2 个研究点分布在 1 个国家目标入组 70 人开始时间: 2013年1月最近更新: 2017年2月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: The University of New South Wales
入组人数: 70
试验地点: 2
主要终点: Montgomery Asberg Depression Rating Scale for Depression (MADRS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a RCT of transcranial electrical stimulation in depressed patients. 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: Triple (Participant, 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

•DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
•MADRS score ≥ 20 at study entry.

排除标准

•DSM-IV psychotic disorder;
•drug or alcohol abuse or dependence (preceding 12 months);
•inadequate response to ECT (current episode of depression);
•anticonvulsant or benzodiazepine medication;
•rapid clinical response required, e.g. 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;
•pregnancy.

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

Beck Depression Inventory II(12 weeks)

研究者

发起方

The University of New South Wales

申办方类型

Other

责任方

Principal Investigator

主要研究者

Colleen Loo

Professor

The University of New South Wales

研究点 (2)

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