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
: November 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Device: Deep Brain Stimulator, implantable | 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 (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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Deep Brain Stimulation for Treatment Resistant Depression |
Study Start Date : | September 2006 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | September 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: DBS for Treatment Resistant Depression
Deep Brain Stimulation for Treatment Resistant Depression.
|
Device: Deep Brain Stimulator, implantable
Deep Brain Stimulator
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- decrease in Hamilton Depression Rating Scale-24 score of at least 50% at 6 months open treatment [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Minimum Eligibility Criteria
- Age 18-70 years old.
- Currently insured or receiving Medicare.
- Ability to provide written informed consent.
- Diagnosis of a Major Depressive Episode or Bipolar Type II - current episode depressed
- Current episode duration of at least 1 year
- Failure to respond to a minimum of four different antidepressant treatments.
- Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode.
- All patients must have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist
- Willing to temporarily relocate to the Atlanta area for at least 3-4 months and return for all required follow-up visits

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 Quinn | 404-727-9228 | dbs@emory.edu | |
Contact: Lydia Denisson | 404-712-1580 | dbs@emory.edu |
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Helen Mayberg, Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT00367003 History of Changes |
Other Study ID Numbers: |
IRB00024883 |
First Posted: | August 22, 2006 Key Record Dates |
Last Update Posted: | November 6, 2017 |
Last Verified: | November 2017 |
Keywords provided by Helen Mayberg, Emory University:
Depression, Unipolar, Bipolar-II, DBS, Imaging |
Additional relevant MeSH terms:
Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant |
Behavioral Symptoms Mood Disorders Mental Disorders |