Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive Compulsive Scale, Y-BOCS
研究概览
简要总结
The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).
The main research questions are:
- Does active DBS in BNST reduce OCD symptoms (primary outcome)?
- Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?
The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.
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, Outcomes Assessor)
盲法说明
The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- •The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
- •Severe OCD symptoms: YBOCS ≥ 25 points.
- •Substantial incapacity because of his/her symptoms.
- •Duration of symptoms: 5 years minimum.
- •Understand the consequences of participation in the study and give informed written consent.
排除标准
- •Not being able to understand the consequences of the treatment.
- •Diagnosed with intellectual disability according to DSM-IV.
- •Not meeting the requirements for the neurosurgery procedure.
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale, Y-BOCS
时间窗: From enrollment to the end of treatment after 6 months.
Validated psychometric scale that measures symptoms of OCD.
次要结局
- Hamilton Anxiety Scale, HAS(From enrollment to the end of treatment after 6 months.)
- Hamilton Depression scale, HAMD(From enrollment to the end of treatment after 6 months.)
- Montgomery Asberg Depression Rating Scale, MADRS(From enrollment to the end of treatment after 6 months.)
- Global Assessment of Functioning, GAF(From enrollment to the end of treatment after 6 months.)
- Clinical Global Impression rating scale, CGI(From enrollment to the end of treatment after 6 months.)