Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

Not Applicable

• Conditions: Anorexia Nervosa
• Interventions: Procedure: Deep brain stimulation; Other: Fluoxetine

• Registration Number: NCT02593695
• Lead Sponsor: Tang-Du Hospital

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 available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-30
• Status Verified: 2015-11
• Study First Posted: 2015-11-01
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep brain stimulation	Continuous deep brain stimulation of bilateral nucleus accumbens
Standard Control	Fluoxetine	Fluoxetine

Primary Outcome Measures

Name	Time	Method
BMI	6 month

Secondary Outcome Measures

Name	Time	Method
weight	6 month
Yale-Brown Obsessive Compulsive Scale	6 month	Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Self-Rating Depression Scale	6 month	Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
The Symptom Checklist-90	6 month	The Symptom Checklist-90(SCL-90) is used to evaluate general status.

Trial Locations

Locations (1)

Department of neurosurgery, Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China