Skip to main content
Clinical Trials/NCT00367003
NCT00367003
Active, not recruiting
Not Applicable

Deep Brain Stimulation for Treatment Resistant Depression

Emory University1 site in 1 country37 target enrollmentSeptember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Emory University
Enrollment
37
Locations
1
Primary Endpoint
Change in Hamilton Depression Rating Scale-17 Score
Status
Active, not recruiting
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
January 2029
Last Updated
12 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patricio Riva Posse

Assistant Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Hamilton Depression Rating Scale-17 Score

Time Frame: Baseline, Week 24 post-intervention

The Hamilton Depression Rating Scale (HDRS-17) contains 17 items that are scored from 0 to 2, 3, or 4, where 0 is lack of difficulty and the highest number for an item is the most extreme difficulty. Total scores range from 0 to 53 and higher scores indicate greater depression. For this study, a response to treatment will be defined as a decrease in the HDRS-17 score of 50% or greater from the average pre-surgical baseline.

Study Sites (1)

Loading locations...

Similar Trials