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

NCT03667872 | Unknown

• 1 other identifier: PINS-029
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depressive Disorder

Keywords

Deep Brain Stimulation; Habenula; Functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change in the Hamilton Anxiety Scale

  Change in the Hamilton Anxiety Scale after the DBS on

  Baseline（preoperative）,3 months, 6 months, 12months

Study Arms (1)

Device

EXPERIMENTAL

MRI compatible and LFP recordable implantable stimulator

Procedure: Bilateral implantation of DBS system to Habeluna

Interventions

Bilateral implantation of DBS system to Habeluna PROCEDURE

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

Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

Study Sites (1)

Habenula DBS

Shenzhen, Shenzhen, China

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Zhiyan Wang

CONTACT

010-60736388; wzyann@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: January 15, 2019
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2022
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

CN (1)