Deep Brain Stimulation for Treatment Resistant Depression
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|ClinicalTrials.gov Identifier: NCT00367003|
Recruitment Status : Recruiting
First Posted : August 22, 2006
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Deep Brain Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation for Treatment Resistant Depression|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
Experimental: Deep Brain Stimulation
Participants with treatment resistant depression will have a device implanted for deep brain stimulation.
Device: Deep Brain Stimulation
The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.
- Change in Hamilton Depression Rating Scale-17 Score [ Time Frame: Baseline, Week 30 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367003
|Contact: Sinead Quinnfirstname.lastname@example.org|
|Contact: Reed Gilbert||404-712-1580|
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Sinead Quinn 404-727-9228 email@example.com|
|Sub-Investigator: Robert Gross, M.D., Ph.D.|
|Principal Investigator: Patricio Riva Posse, MD|
|Sub-Investigator: Andrea Cowell, MD|
|Sub-Investigator: Helen Mayberg, MD|
|Principal Investigator:||Patricio Riva Posse, MD||Emory University|