NCT00533832已完成不适用
A Multicernter, Pivotal, Safety and Efficacy Study of the NeuroCtybernetic Prosthesis (NCP(R)) System in Patients With Depression
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
- 266
- 试验地点
- 1
研究概览
简要总结
To confirm the safety and efficacy of the NCP System in treating patients in a nmajor depressive episode.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with major depressive episode (MDE)
- •chronic (>=2 years)or recurrent (>-=4) lifetime MDEs
- •resistant to >=2 treatments from different categories
- •completed >=6 weeks of psychotherapy
- •score >=20 on 24-item Hamilton Rating Scale of Depression
- •stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for >=4 weeks before Visit B1
- •stable on atypical antipsychotic and anticonvulsant medications as for item #7
- •age >=18 amd <=80 years
- •male or nonpregnant female adequately protected from conception.
- •able to comply with testing and follow-up visits
- •voluntarily signed informed consent
- •patients with bipolar disorder demonstrated a resistance to lithium treatment or has a medical contraindication to treatment with lithium or is known to be intolerant to lithium (not applicable to patients with MDD)
排除标准
- •atypical depression at study entry or psychotic symptoms in any MDE
- •history of schizophrenia, schizoaffective disorder, or delusional disorders
- •rapid cycling bopolar disorder
- •secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders
- •failed 7 or more antidepressant treatments
- •a. suicide attempt requiring medical attention within previous 12 months b. >=2 suicide attempts in the past 12 months c. cannot guarantee that will not implement suicide d. likely to attempt suicide within next 6 mon in investigator's opinion
- •alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse
- •history of myocardial infarction or cardiac arrest
- •other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult
- •received general anesthesia with 390 days before enrollment.
- •taken an investigational drug within a clearance duration of 5 x the half-life of the investigational drug or within <=4weeks before Visit B1, whichever time is greater
- •enrolled in another investigational study
- •using another investigational device
- •significant cardiac or pulmonary condition currently under treatment resulting in an ASA score >=III
- •history of, or evidence of, significant brain malformation or significant head injury or clinically apparent cerebral vascular events, or prior brain surgery such as cingulatomy
- •unilateral or bilateral cervical vagotomy
- •demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
- •likely to require a whole body MRI after NCP implantation
- •currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation
- •plans to relocate or move to a location distant from the study site within one year of enrollment
- •previously enrolled in this or any other NCP System study -
研究组 & 干预措施
1
Active Comparator
Patients implanted with the vagus nerve stimulation (VNS) device and receiving VNS Intervention: vagus nerve stimulation (VNS)
干预措施: vagus nerve stimulation (VNS) (Device)
2
Placebo Comparator
Implanted with vagus nerve stimulation (VNS) device, but not receiving VNS
干预措施: vagus nerve stimulation (VNS) (Device)
研究者
研究点 (1)
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