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Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deep brain stimulation
Fluoxetine
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of neurosurgery, Tangdu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep Brain Stimulation

Standard Control

Arm Description

Continuous deep brain stimulation of bilateral nucleus accumbens

Fluoxetine

Outcomes

Primary Outcome Measures

BMI

Secondary Outcome Measures

weight
Yale-Brown Obsessive Compulsive Scale
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Self-Rating Depression Scale
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
The Symptom Checklist-90
The Symptom Checklist-90(SCL-90) is used to evaluate general status.

Full Information

First Posted
October 14, 2015
Last Updated
November 9, 2015
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02593695
Brief Title
Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa
Official Title
Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Continuous deep brain stimulation of bilateral nucleus accumbens
Arm Title
Standard Control
Arm Type
Active Comparator
Arm Description
Fluoxetine
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Other Intervention Name(s)
DBS
Intervention Description
Deep brain stimulation of bilateral nucleus accumbens
Intervention Type
Other
Intervention Name(s)
Fluoxetine
Intervention Description
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
Primary Outcome Measure Information:
Title
BMI
Time Frame
6 month
Secondary Outcome Measure Information:
Title
weight
Time Frame
6 month
Title
Yale-Brown Obsessive Compulsive Scale
Description
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Time Frame
6 month
Title
Self-Rating Depression Scale
Description
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
Time Frame
6 month
Title
The Symptom Checklist-90
Description
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years of age, male or female patients. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition). BMI<16. Long-term pharmacotherapy resistance. Written informed consent. normal intelligence and compliance Exclusion Criteria: 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； History of severe neuropsychiatric disease； Epilepsy； severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension； Severe diabetes ,severe cardiovascular and cerebrovascular disease； Malignant tumor； Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female； Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-dong Gao, M.D.
Organizational Affiliation
Department of neurosurgery, Tangdu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurosurgery, Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China

12. IPD Sharing Statement

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Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

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