Back to resultsEfficacy and Safety of DBS in Patients With Treatment-Resistant Depression
Primary Purpose
Treatment Resistant Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bilateral implantation of DBS system to Habeluna
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depressive Disorder focused on measuring Deep Brain Stimulation, Habenula, Functional magnetic resonance imaging
Eligibility Criteria
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.
Sites / Locations
- Habenula DBS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device
Arm Description
MRI compatible and LFP recordable implantable stimulator
Outcomes
Primary Outcome Measures
Change in the Hamilton Anxiety Scale
Change in the Hamilton Anxiety Scale after the DBS on
Secondary Outcome Measures
Full Information
NCT ID
NCT03667872
First Posted
September 10, 2018
Last Updated
December 24, 2018
Sponsor
Beijing Pins Medical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03667872
Brief Title
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
Official Title
Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Anticipated)
Primary Completion Date
June 18, 2020 (Anticipated)
Study Completion Date
June 18, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depressive Disorder
Keywords
Deep Brain Stimulation, Habenula, Functional magnetic resonance imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Experimental
Arm Description
MRI compatible and LFP recordable implantable stimulator
Intervention Type
Procedure
Intervention Name(s)
Bilateral implantation of DBS system to Habeluna
Intervention Description
Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna
Primary Outcome Measure Information:
Title
Change in the Hamilton Anxiety Scale
Description
Change in the Hamilton Anxiety Scale after the DBS on
Time Frame
Baseline（preoperative）,3 months, 6 months, 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyan Wang
Phone
010-60736388
Email
wzyann@126.com
Facility Information:
Facility Name
Habenula DBS
City
Shenzhen
State/Province
Shenzhen
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Cai
Phone
0755-83366388
First Name & Middle Initial & Last Name & Degree
Yingli Zhang
Phone
0755-25533524
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
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