Deep Brain Stimulation for Treatment Resistant Depression
|Major Depressive Disorder||Device: Deep Brain Stimulator, implantable||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Deep Brain Stimulation for Treatment Resistant Depression|
- decrease in Hamilton Depression Rating Scale-24 score of at least 50% at 6 months open treatment [ Time Frame: 6 months ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: DBS for Treatment Resistant Depression
Deep Brain Stimulation for Treatment Resistant Depression.
Device: Deep Brain Stimulator, implantable
Deep Brain Stimulator
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 (Kennedy and Lam 2003; UK ECT Review Group 2003). For patients who remain severely depressed despite these aggressive approaches, new strategies are needed.
Specific Aim 1. To asses the safety and tolerability of acute and chronic Cg25-DBS.
Specific Aim 2. To assess the antidepressant efficacy of active Cg25-DBS in treatment-resistant depressed patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367003
|United States, Georgia|
|Emory University School of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator: Helen Mayberg, M.D.|
|Sub-Investigator: Roberg Gross, M.D., Ph.D.|
|Sub-Investigator: Patricio Riva Posse, MD|
|Sub-Investigator: Steven Garlow, MD|
|Principal Investigator:||Helen Mayberg, M.D.||Emory University|