NCT02263404Unknown早期 1 期
PINS Stimulator System to Treat Severe Anorexia Nervosa
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 16
- 主要终点
- Eating Disorder Related Preoccupations and Rituals
研究概览
简要总结
Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients aged 20-60 years.
- •Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
- •Chronicity or treatment resistance shown by some or all of:
- •A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment.
- •A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding.
- •A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
- •Able to provide informed consent.
- •Able to comply with all testing, follow-ups, and study appointments and protocols.
排除标准
- •Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
- •Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
- •Patients with serious infectious disease.
- •Patients with history of serious neurological or psychiatrical diseases.
- •Person with history of HIV infection or serious malnutrition.
- •Dependent upon and addicted to multiple drugs.
- •Any contraindication to MRI or PET scanning.
- •Body-mass index less than
- •Attended some other trials within one year.
结局指标
主要结局
Eating Disorder Related Preoccupations and Rituals
时间窗: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
次要结局
- Hamilton Depression Rating Scale(Change from baseline at 3 months, 6 months and 12 months)
- Health Survey Short Form (SF-36)(Change from baseline at 3 months, 6 months and 12 months)
研究者
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