Anorexia Nervosa
Conditions
Brief summary
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.
Interventions
DEVICEDeep Brain Stimulation
DBS Implant Stimulation
Sponsors
Beijing Tiantan Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Female or male patients aged 20-60 years. 2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). 3. 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. 4. Able to comply with all testing, follow-ups, and study appointments and protocols.
Exclusion criteria
1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide. 2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems. 3. Patients with serious infectious disease. 4. Patients with history of serious neurological or psychiatrical diseases. 5. Person with history of HIV infection or serious malnutrition. 6. Dependent upon and addicted to multiple drugs. 7. Any contraindication to MRI or PET scanning. 8. Body-mass index less than 13. 9. Attended some other trials within one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eating Disorder Related Preoccupations and Rituals | Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactJia Fumin, PhD
Outcome results
None listed