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Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01476540
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011

November 15, 2011
November 17, 2011
July 2011
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476540 on ClinicalTrials.gov Archive Site
  • Depression [ Time Frame: Change from baseline in depression scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI)
  • Anxiety [ Time Frame: Change from baseline in anxiety scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory (BAI)
  • Quality of Life [ Time Frame: Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Health Survey Short Form (SF36), Quality of Life Scale
Same as current
Not Provided
Not Provided
 
Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa

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 to a greater understanding of its underlying pathophysiology, although few significant advances in treatment have been made in the last half-century. The central features of AN, which include an intense fear of gaining weight, a refusal to maintain a normal weight, as well as significant anxiety, anhedonia and dysphoria surrounding food, have been linked to dysfunction in key brain structures and circuits. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the insertion of electrodes into structures believed to drive pathological behavior. The procedure is approved for the management of movement disorders, such as Parkinson's Disease, and has shown promising early results in the management of some psychiatric conditions, such as Major Depression. The purpose of this study is to explore the safety and initial efficacy of DBS, in patients with treatment resistant AN.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anorexia Nervosa
Procedure: Deep Brain Stimulation
Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.
Not Provided
Lipsman N, Woodside DB, Giacobbe P, Hamani C, Carter JC, Norwood SJ, Sutandar K, Staab R, Elias G, Lyman CH, Smith GS, Lozano AM. Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial. Lancet. 2013 Apr 20;381(9875):1361-70. doi: 10.1016/S0140-6736(12)62188-6. Epub 2013 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Not Provided
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

    1. 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;
    2. 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;
    3. 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 Criteria:

  • 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
Both
20 Years to 60 Years
No
Contact: Nir Lipsman, MD 416-790-1780 nir.lipsman@utoronto.ca
Canada
 
NCT01476540
10-0991-A
No
Andres M. Lozano, University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Andres M Lozano, MD, PhD University Health Network, Toronto
Principal Investigator: Blake Woodside, MD Toronto General Hospital
University Health Network, Toronto
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP