This trial is active, not recruiting.

Condition anorexia nervosa
Treatments deep brain stimulation, fluoxetine
Sponsor Tang-Du Hospital
Start date October 2015
End date December 2017
Trial size 10 participants
Trial identifier NCT02593695, ANDBS


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Continuous deep brain stimulation of bilateral nucleus accumbens
deep brain stimulation DBS
Deep brain stimulation of bilateral nucleus accumbens
(Active Comparator)
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Primary Outcomes

time frame: 6 month

Secondary Outcomes

time frame: 6 month
Yale-Brown Obsessive Compulsive Scale
time frame: 6 month
Self-Rating Depression Scale
time frame: 6 month
The Symptom Checklist-90
time frame: 6 month

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Principal investigator Guo-dong Gao, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Tang-Du Hospital.