NCT02253472Unknown早期 1 期
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 主要终点
- Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)
研究概览
简要总结
The purpose of this clinical study is To verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Obsessive-Compulsive Disorder.
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)
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
- •Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis.
- •Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale.
- •Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance).
- •Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response Prevention" of a minimum of 20 sessions with a documented lack of efficiency.
- •6.The ability to give written and informed consent.
排除标准
- •Co-morbid psychotic disorder according to DSM-IV criteria
- •Suicidal tendencies in the last 6 months
- •History of cerebral trauma
- •Clinically relevant internal or neurological disorder
- •Substance misuse or dependence in the last six months
- •Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS
- •Participate in other clinical trial
- •The investigator and/or enrollment review committee, would preclude participation in the study
结局指标
主要结局
Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)
时间窗: 12 month
次要结局
- Hamilton anxiety scale (HAMD)(12 month)
研究者
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