DBS of the Habenula for Treatment- Resistant Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2021-05-30

Brief Summary

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The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness and safety of bilateral DBS to habenula for patients with TRD. This study will also use structural and functional MRI to explore the underlying mechanism of Hb's effects on TRD.

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Detailed Description

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Conditions

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Treatment Resistant Major Depression Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will receive bilateral surgical implantation of DBS system.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation of Bilateral Habenula

Group Type EXPERIMENTAL

Deep brain stimuation system implantation

Intervention Type PROCEDURE

All subjects will receive bilateral surgical implantation of DBS system.The Medtronic DBS 3389 electrode is utilized in this study. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller.

Interventions

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Deep brain stimuation system implantation

All subjects will receive bilateral surgical implantation of DBS system.The Medtronic DBS 3389 electrode is utilized in this study. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller.

Intervention Type PROCEDURE

Other Intervention Names

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DBS Activa RC System

Eligibility Criteria

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Inclusion Criteria

* Men and women(non-pregnant) aged 18-65 years old;
* DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5) of a current major depressive episode(MDE), either nonpsychotic unipolar major depressive disorder (MDD) or bipolar disorder (BD);
* Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months) and a minimum of 5 y since the onset of the first depressive episode;
* For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder)
* Treatment resistance defined as Failure of at least 3 adequate treatments from at least two distinctly different classes (SSRI, SNRI, NaSSA, TCA+, lithium-addition) for a period of 6-8 weeks. If diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone).
* At least 1 session of ECT, for which the series of ECT was terminated either due to adverse effects or insufficient response (including at least 6 sessions of bilateral ECT). Or unable to recieve ECT.
* Symptom Severity: HAMD-17 total ≥21;
* Stable antidepressant medical regimen for the month preceding surgery;
* Anticipates a stable psychotropic medication regimen in the next 12 months;
* Able and willing to give written informed consent;
* Modified mini-mental state examination (MMSE) score ≥ 27；

Exclusion Criteria

* Schizophrenia /history of psychosis unrelated to MDD;
* Severe personality disorder (assessed by SCID-II);
* Alcohol or substance abuse/dependence within 6 months, excluding nicotine dependence;
* Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year;
* Neurological disease (e.g., Parkinson's disease)
* Any history of seizure disorder or hemorrhagic stroke;
* Abnormal brain MRI ;
* Previous sterosurgery;
* Any medical contraindication to surgery;
* Does not have adequate family/friend support as determined by psychological screening and/or interview;
* Unable to maintain a stable psychotropic medication regimen in the next 12 months;
* Pregnant or has plans to become pregnant in the next 12 months;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No