Deep Brain Stimulation for Treatment-Refractory Major Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.
详细描述
Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depression (MD), severe, unipolar type
- •German mother tongue
- •Hamilton Depression Rating Scale (HDRS24) score of > 20
- •Global Assessment of Function (GAF) score of < 45
- •At least 4 episodes of MD or chronic episode > 2 years
- •> 5 years after first episode of MD
- •Failure to respond to *adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
- •adequate trials (>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant); *an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and; *an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
- •Able to give written informed consent
- •No medical comorbidity
- •Drug free or on stable drug regimen at least 6 weeks before study entry
排除标准
- •Current or past nonaffective psychotic disorder
- •Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- •Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- •Any surgical contraindications to undergoing DBS
- •Current or unstably remitted substance abuse (aside from nicotine)
- •Pregnancy and women of childbearing age not using effective contraception
- •History of severe personality disorder
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS)
时间窗: analyzed at 12 and 24 month after stimulation onset
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS)(analyzed at 12 and 24 month after stimulation onset)
研究者
Thomas E. Schlaepfer, MD
Professor of Psychiatry and Psychotherapy
University Hospital, Bonn