NCT00531726已完成不适用
Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- HAMD/MARS score reduction
研究概览
简要总结
In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient is diagnosed with a severe major depressive episode
- •patient is in a chronic current MDE and/or has had a history of recurrent MDEs
- •patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
- •patient has a score > 20 on the HAMD24
- •patient is stable on current psychotropic medication for at least 6 weeks
- •patient is >25 and <80 years
- •Global Assessment of Function (GAF) score of < 45
排除标准
- •Atypical Depression (according to DSM IV)
- •Other relevant psychiatric axis I or axis II diseases
- •Relevant neurological diseases
- •Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score > 3)
- •Patient is currently enrolled in another investigational study not associated with the current study
- •Patient has a history of, or evidence of, significant brain malformation or significant head injury
- •Patient is likely to require a whole body MRI after implantation
研究组 & 干预措施
B
Sham Comparator
干预措施: DBS of Cg25 (Device)
A
Experimental
干预措施: DBS of Cg25 (Device)
结局指标
主要结局
HAMD/MARS score reduction
时间窗: 4 weeks
次要结局
- neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures(4 weeks)
研究者
Malek Bajbouj
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
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