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Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT02593695
Recruitment Status : Unknown
Verified November 2015 by Guodong Gao, Tang-Du Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE November 2, 2015
Last Update Posted Date November 10, 2015
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
BMI [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02593695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • weight [ Time Frame: 6 month ]
  • Yale-Brown Obsessive Compulsive Scale [ Time Frame: 6 month ]
    Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
  • Self-Rating Depression Scale [ Time Frame: 6 month ]
    Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
  • The Symptom Checklist-90 [ Time Frame: 6 month ]
    The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa
Official Title  ICMJE Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Brief Summary Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anorexia Nervosa
Intervention  ICMJE
  • Procedure: Deep brain stimulation
    Deep brain stimulation of bilateral nucleus accumbens
    Other Name: DBS
  • Other: Fluoxetine
    Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
Study Arms  ICMJE
  • Experimental: Deep Brain Stimulation
    Continuous deep brain stimulation of bilateral nucleus accumbens
    Intervention: Procedure: Deep brain stimulation
  • Active Comparator: Standard Control
    Fluoxetine
    Intervention: Other: Fluoxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18 and 65 years of age, male or female patients.
  2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
  3. BMI<16.
  4. Long-term pharmacotherapy resistance.
  5. Written informed consent.
  6. normal intelligence and compliance

Exclusion Criteria:

  1. Surgical contradiction(implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS)or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions; History of brain trauma;
  2. History of severe neuropsychiatric disease;
  3. Epilepsy;
  4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension;
  5. Severe diabetes ,severe cardiovascular and cerebrovascular disease;
  6. Malignant tumor;
  7. Being using anticoagulant or showing clinical hemorrhagic tendency; Pregnant female;
  8. Patients are taking part in other clinical trials in recent 3months; Being deem as unfit for the trials by researcher
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593695
Other Study ID Numbers  ICMJE ANDBS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guodong Gao, Tang-Du Hospital
Study Sponsor  ICMJE Tang-Du Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guo-dong Gao, M.D. Department of neurosurgery, Tangdu Hospital
PRS Account Tang-Du Hospital
Verification Date November 2015

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