Deep Brain Stimulation for Treatment Resistant Depression
This study is currently recruiting participants.
Verified October 2012 by Emory University
Sponsor:
Emory University
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00367003
First received: August 18, 2006
Last updated: October 22, 2012
Last verified: October 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 18, 2006 | ||||||||
| Last Updated Date | October 22, 2012 | ||||||||
| Start Date ICMJE | September 2006 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
decrease in Hamilton Depression Rating Scale-24 score of at least 50% at 6 months open treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
decrease in Hamilton Depression Rating Scale-24 score of less than or equal to 50% at 6 months open treatment | ||||||||
| Change History | Complete list of historical versions of study NCT00367003 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Deep Brain Stimulation for Treatment Resistant Depression | ||||||||
| Official Title ICMJE | Deep Brain Stimulation for Treatment Resistant Depression | ||||||||
| Brief Summary | The purpose of the proposed study is to evaluate the safety, feasibility and efficacy of chronic, high frequency stimulation of the subgenual cingulate white matter (Cg25WM) using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for severe treatment-refractory Major Depression in twenty TRD patients, and to investigate potential mechanisms of action of this intervention. |
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| 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 (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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Major Depressive Disorder | ||||||||
| Intervention ICMJE | Device: Deep Brain Stimulator, implantable
Deep Brain Stimulator |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | September 2014 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Minimum Eligibility Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00367003 | ||||||||
| Other Study ID Numbers ICMJE | #1317-2005 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Helen Mayberg, Emory University | ||||||||
| Study Sponsor ICMJE | Emory University | ||||||||
| Collaborators ICMJE | The Dana Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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