Status:
UNKNOWN
PINS Stimulator System to Treat Severe Anorexia Nervosa
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
20-60 years
Phase:
EARLY_PHASE1
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 cos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 13.
- Attended some other trials within one year.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02263404
Start Date
December 1 2016
End Date
December 1 2018
Last Update
October 14 2016
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