Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2006-08-18
Brief Title:
Deep Brain Stimulation for Treatment Resistant Depression
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Deep Brain Stimulation for Treatment Resistant Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety efficacy and mechanism of action of subgenual cingulate Cg25 deep brain stimulation DBS for major depression in patients who have not responded to prior antidepressant treatments Participation in the study will continue for ten years or until the device receives FDA approval for depression Forty 40 patients will be enrolled in this study
Detailed Description:
Major Depression is one of the most common and costly of all psychiatric disorders While depression can be effectively treated in the majority of patients by either medication or some form of evidence-based psychotherapy up to 20 of patients fail to respond to standard interventions For these patients trial-and-error combinations of multiple medications and electroconvulsive therapy are often required For patients who remain severely depressed despite these aggressive approaches new strategies are needed
Converging clinical biochemical neuroimaging and post-mortem data suggest depression is unlikely to be a disease of a single brain region or neurotransmitter system Rather it is now generally viewed as a systems-level disorder affecting integrated pathways linking select cortical subcortical and limbic sites and their related neurotransmitter and molecular mediators Treatments for depression can be viewed within a limbic-cortical system framework where different modes of treatment modulate specific regional targets resulting in a variety of complementary adaptive chemical and molecular changes that re-establish a normal mood state Functional neuroimaging studies have played a critical role in characterizing these limbic-cortical pathways Previous studies have demonstrated consistent involvement of the subgenual cingulate Cg25 in both acute sadness and antidepressant treatment effects suggesting a critical role for this region in modulating negative mood states
This study will test whether high frequency deep brain stimulation of the subgenual cingulate white matter Cg25-DBS is a safe and efficacious antidepressant treatment in forty patients with treatment resistant depression and to investigate potential mechanisms of action of this intervention
Converging clinical biochemical neuroimaging and post-mortem data suggest depression is unlikely to be a disease of a single brain region or neurotransmitter system Rather it is now generally viewed as a systems-level disorder affecting integrated pathways linking select cortical subcortical and limbic sites and their related neurotransmitter and molecular mediators Treatments for depression can be viewed within a limbic-cortical system framework where different modes of treatment modulate specific regional targets resulting in a variety of complementary adaptive chemical and molecular changes that re-establish a normal mood state Functional neuroimaging studies have played a critical role in characterizing these limbic-cortical pathways Previous studies have demonstrated consistent involvement of the subgenual cingulate Cg25 in both acute sadness and antidepressant treatment effects suggesting a critical role for this region in modulating negative mood states
This study will test whether high frequency deep brain stimulation of the subgenual cingulate white matter Cg25-DBS is a safe and efficacious antidepressant treatment in forty patients with treatment resistant depression and to investigate potential mechanisms of action of this intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None