Status:
COMPLETED
Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Lead Sponsor:
University Health Network, Toronto
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
Anorexia Nervosa (AN) is a challenging, chronic, refractory illness with the highest mortality rate of any psychiatric condition. Advances in the neuroimaging, genetics and neurobiology of AN has led ...
Detailed Description
Anorexia nervosa is a chronic, and debilitating psychiatric disorder associated with the highest mortality rate of any psychiatric condition. Despite advances in neuroimaging, genetics, pharmacology a...
Eligibility Criteria
Inclusion
- Female or Male patients between age 20-60
- Diagnosis of Anorexia Nervosa, restricting or binge-purging subtype as defined by the Diagnostic and Statistical Manual (DSM-IVR)
- Chronicity and/or Treatment Resistance as demonstrated by some or all of:
- A pattern of three year's duration of relentless unresponsiveness to repeated voluntary hospitalizations, characterized by failure to complete treatment of immediate weight relapse following treatment;
- pattern of increasing medical instability accompanied by refusal to participate in/lack of responsiveness to intensive expert treatment and increasing medical acuity, lasting at least two years and involving at least two episodes of involuntary feeding;
- A pattern of chronic stable AN lasting at least 10 years
- Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion
- Any past or current evidence of psychosis
- Active neurologic disease such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
- Likely to relocate or move during the study's one year duration
- BMI less than 13
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of AN or not, that will result in significant risk from a surgical procedure.
- Pregnancy
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01476540
Start Date
July 1 2011
End Date
February 1 2014
Last Update
October 30 2019
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8