PINS Stimulator System to Treat Severe Anorexia Nervosa

Beijing Pins Medical Co., Ltd0 sites16 target enrollmentDecember 2016

ConditionsAnorexia Nervosa

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Anorexia Nervosa
Sponsor: Beijing Pins Medical Co., Ltd
Enrollment: 16
Primary Endpoint: Eating Disorder Related Preoccupations and Rituals
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

December 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Pins Medical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

Eating Disorder Related Preoccupations and Rituals

Time Frame: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months

Secondary Outcomes

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)