Safety and Effectiveness of Capsulotomy in Refractory Obsessive-Compulsive Disorder
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Y-BOCS Score
研究概览
简要总结
Obsessive-compulsive disorder (OCD) is a severely disabling psychiatric disorder with a worldwide lifetime prevalence of 2-3% (Islam et al., 2015).Despite the efficacy of pharmacological and behavioural treatment methods for most OCD patients, roughly one third do not demonstrate significant symptom improvement, even after aggressive treatment (Foa et al, 2007). The effectiveness of neurosurgical treatment methods (including ablative surgery) for those with severely disabling treatment resistant OCD is substantiated by clinical research (Greenberg, Rauch & Haber, 2010). The brain target of this procedure is usually the area between the anterior and middle third of the anterior limb of the internal capsule.
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
- 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 as the primary psychiatric diagnosis (according to DSM IV-criteria).
- •Severity: Score higher than 25 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
- •Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (refractory).
- •Refractory: a lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least three serotonin-reuptake inhibitors, and clomipramine. Adequate psychotherapy, defined as continuously treatment for more than six months with a certified therapist .
排除标准
- •Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0);
- •Cluster A or B personality disorder according to DSM-IV criteria, as assessed with the use of the Structured Clinical Interview II.
- •A current severe major depressive episode, determined according to DSM-IV criteria (as assessed with the use of the MINI 6.0.0) and defined by HAMD-17 score of more than 20 and a risk of suicide.
- •Abnormal cognitive status (measured by MoCA)
研究组 & 干预措施
Surgical Intervention
干预措施: Anterior Capsulotomy (Procedure)
结局指标
主要结局
Change in Y-BOCS Score
时间窗: Baseline (preoperative), 3 months, 6 months
次要结局
- WHO disability assessment 2.0 (self, 12 terms)(Baseline (preoperative), 3 months, 6 months)
- Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score(Baseline (preoperative), 3 months, 6 months)
- Change in Temperament and Character Inventory revised version (TCI-R) Score(Baseline (preoperative), 3 months, 6 months)
- Change in Clinical Global Impressions Scale Score(Baseline (preoperative), 3 months, 6 months)
- Change in functional magnetic resonance imaging (fMRI) images(Baseline (preoperative), 3 months, 6 months)
- Change in Psychophysical tasks（ Iowa Gambling Task , Model Task, Working memory task ）(Baseline (preoperative), 3 months, 6 months)
研究者
Bomin Sun
Director of the Department of Functional Neurosurgery
Ruijin Hospital