Anorexia NervosaNCT02593695
Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa
A study testing Deep brain stimulation and Fluoxetine in people with Anorexia Nervosa, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Deep brain stimulation and Fluoxetine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
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.
- Conditions
- Anorexia Nervosa
- Being tested
- Deep brain stimulation, Fluoxetine
- Keywords
- Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Also called DBS
Deep brain stimulation of bilateral nucleus accumbens
FluoxetineOther
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Continuous deep brain stimulation of bilateral nucleus accumbens Receives: Procedure: Deep brain stimulation |
| Standard Control | Active comparator | Fluoxetine Receives: Other: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: 6 month
Secondary outcomes (4)
weight
Measured: 6 month
Yale-Brown Obsessive Compulsive Scale
Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.
Measured: 6 month
Self-Rating Depression Scale
Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.
Measured: 6 month
The Symptom Checklist-90
The Symptom Checklist-90(SCL-90) is used to evaluate general status.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guodong Gao, Tang-Du Hospital
- Investigators
- Guo-dong Gao, M.D., Principal investigator, Department of neurosurgery, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593695
- Sponsor's protocol ID
- ANDBS
- Status last verified
- Nov 2015
- First submitted
- 14 Oct 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02593695
- Acronym / sponsor ID
- ANDBS
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Deep Brain Stimulation, Nucleus accumbens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep brain stimulationContinuous deep brain stimulation of bilateral nucleus accumbens |
| Standard Control | Active comparator | Other: FluoxetineFluoxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationAlso: DBSDeep brain stimulation of bilateral nucleus accumbens | Procedure or surgery | Deep Brain Stimulation |
| FluoxetineFluoxetine is one of selective serotonin reuptake inhibitors(SSRIs). | Other | Standard Control |
Primary outcome
BMI
Time frame: 6 month
4 secondary outcomes
weight
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo-dong Gao, M.D. principal investigator
Department of neurosurgery, Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation and Fluoxetine in people with Anorexia Nervosa, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.