Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression

Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03667872

Enrollment

Registered

2018-09-12

Start date

2019-01-15

Completion date

2022-06-18

Last updated

2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depressive Disorder

Keywords

Deep Brain Stimulation, Habenula, Functional magnetic resonance imaging

Brief summary

The habenula (Hb) is an ancient 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 indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.

Interventions

PROCEDUREBilateral implantation of DBS system to Habeluna

Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age 18-70 years old; * DSM-IV diagnosis of Major depression disorder of psychiatrists; * More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments; * Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode; * HAMD-17≥20; * GAF≤50； * Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion criteria

* Obvious medical and psychiatric comorbidities; * Alcohol or substance abuse/dependence within 12 months; * Antisocial personality disorder, dementia, current tic disorder; * Subject has a history of 2 or more suicide attempts \< 12 months prior to the screening testing; * Pregnancy and/or lactation; * There are contraindications for DBS surgery and chronic stimulation.

Design outcomes

Primary

Measure	Time frame	Description
Change in the Hamilton Anxiety Scale	Baseline（preoperative）,3 months, 6 months, 12months	Change in the Hamilton Anxiety Scale after the DBS on

Countries

China

Contacts

Primary ContactZhiyan Wang

wzyann@126.com010-60736388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026