NCT01849809已完成不适用
Safety and Effectiveness of Gamma Capsulotomy in Intractable Obsessive Compulsive Disorder
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
- 57
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Severity Scale
研究概览
简要总结
A research study of the effectiveness and safety of gamma knife ventral capsulotomy in patients with severe intractable obsessive-compulsive disorder (OCD).
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
盲法说明
Open Label
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 by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Social and Occupational Functioning Assessment Scale (SOFAS) score of 45 or less.
- •Persistence of severe symptoms and impairment for five or more years despite:
- •at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with,
- •adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and
- •augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
- •Age between 18 and 65 years.
- •Able to understand and comply with instructions.
- •Able to give fully informed, written consent in the judgment of the Consent Monitor.
- •Either drug free or on a stable drug regimen for at least 6 weeks.
- •Good general health.
- •A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens.
- •The local referring psychiatrist is willing to provide ongoing care.
排除标准
- •Current or past psychotic disorder.
- •Full-scale IQ below
- •A clinical history of bipolar mood disorder.
- •Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
- •Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
- •Inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia.
- •Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
- •Pregnancy and women of childbearing age not using effective contraception.
- •Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
- •Clinical history of severe personality disorder.
- •Imminent risk of suicide (in the investigators' judgment).
研究组 & 干预措施
Gamma Ventral Capsulotomy
Experimental
干预措施: Gamma Ventral Capsulotomy (Procedure)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Severity Scale
时间窗: Baseline to 5 years
次要结局
未报告次要终点
研究者
Steven Rasmussen
Medical Director, Butler Hospital
Butler Hospital
研究点 (1)
Loading locations...
相似试验
终止
不适用
Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's DiseaseParkinsons DiseaseNCT02249559NYU Langone Health4
进行中（未招募）
不适用
Gamma Knife Radiosurgery for Treatment of Essential TremorEssential TremorNCT02255929Swedish Medical Center183
尚未招募
Unknown
A Clinical Study on Effect of ND:YAG Capsulotomy in posterior capsular opacification after cataract surgery.CTRI/2023/12/060536Dr Rahul Bakhda
招募中
2 期
Efficacy and safety of gamma knife radiosurgery for asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease: A prospective interventional trialasymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau diseaseasymptomatic intracranial hemangioblastomaJPRN-jRCT1032220685Hasegawa Hirotaka20
已完成
不适用
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract ExtractionOpen Angle GlaucomaNCT02784249New World Medical, Inc.166