NCT02593695

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

October 14, 2015

Last Update Submit

November 9, 2015

Conditions

Anorexia Nervosa

Keywords

Anorexia NervosaDeep Brain StimulationNucleus accumbens

Outcome Measures

Primary Outcomes (1)

  • BMI

    6 month

Secondary Outcomes (4)

  • weight

    6 month

  • Yale-Brown Obsessive Compulsive Scale

    6 month

  • Self-Rating Depression Scale

    6 month

  • The Symptom Checklist-90

    6 month

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Continuous deep brain stimulation of bilateral nucleus accumbens

Procedure: Deep brain stimulation

Standard Control

ACTIVE COMPARATOR

Fluoxetine

Other: Fluoxetine

Interventions

Deep brain stimulationPROCEDURE

Deep brain stimulation of bilateral nucleus accumbens

Also known as: DBS
Deep Brain Stimulation
FluoxetineOTHER

Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Standard Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurosurgery, Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Deep Brain StimulationFluoxetine

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativePropylaminesAminesOrganic Chemicals

Study Officials

  • Guo-dong Gao, M.D.

    Department of neurosurgery, Tangdu Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgery Department

Study Record Dates

First Submitted

October 14, 2015

First Posted

November 2, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

CN(1)