Deep Brain Stimulation for Treatment Resistant Depression

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Device: Deep Brain Stimulator, implantable	Not Applicable

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.

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: DBS for Treatment Resistant Depression; Deep Brain Stimulation for Treatment Resistant Depression.	Device: Deep Brain Stimulator, implantable; Deep Brain Stimulator

Outcome Measures

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Primary Outcome Measures :

1. decrease in Hamilton Depression Rating Scale-24 score of at least 50% at 6 months open treatment [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Sinead Quinn	404-727-9228	dbs@emory.edu
Contact: Lydia Denisson	404-712-1580	dbs@emory.edu

Locations

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

Sponsors and Collaborators

Emory University

The Dana Foundation

Investigators

Principal Investigator:	Helen Mayberg, M.D.	Emory University

More Information

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Publications:

Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Filkowski MM, Mayberg HS, Holtzheimer PE. Considering Eligibility for Studies of Deep Brain Stimulation for Treatment-Resistant Depression: Insights From a Clinical Trial in Unipolar and Bipolar Depression. J ECT. 2016 Jun;32(2):122-6. doi: 10.1097/YCT.0000000000000281.

Riva-Posse P, Holtzheimer PE, Garlow SJ, Mayberg HS. Practical considerations in the development and refinement of subcallosal cingulate white matter deep brain stimulation for treatment-resistant depression. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e25-34. doi: 10.1016/j.wneu.2012.11.074. Epub 2012 Dec 13. Review.

Fisher CE, Dunn LB, Christopher PP, Holtzheimer PE, Leykin Y, Mayberg HS, Lisanby SH, Appelbaum PS. The ethics of research on deep brain stimulation for depression: decisional capacity and therapeutic misconception. Ann N Y Acad Sci. 2012 Aug;1265:69-79. doi: 10.1111/j.1749-6632.2012.06596.x. Epub 2012 Jul 19.

Holtzheimer PE, Kelley ME, Gross RE, Filkowski MM, Garlow SJ, Barrocas A, Wint D, Craighead MC, Kozarsky J, Chismar R, Moreines JL, Mewes K, Posse PR, Gutman DA, Mayberg HS. Subcallosal cingulate deep brain stimulation for treatment-resistant unipolar and bipolar depression. Arch Gen Psychiatry. 2012 Feb;69(2):150-8. doi: 10.1001/archgenpsychiatry.2011.1456. Epub 2012 Jan 2.

Christopher PP, Leykin Y, Appelbaum PS, Holtzheimer PE 3rd, Mayberg HS, Dunn LB. Enrolling in deep brain stimulation research for depression: influences on potential subjects' decision making. Depress Anxiety. 2012 Feb;29(2):139-46. doi: 10.1002/da.20916. Epub 2011 Nov 17.

Holtzheimer PE 3rd, Mayberg HS. Deep brain stimulation for treatment-resistant depression. Am J Psychiatry. 2010 Dec;167(12):1437-44. doi: 10.1176/appi.ajp.2010.10010141.

Responsible Party:	Helen Mayberg, Professor, Emory University
ClinicalTrials.gov Identifier:	NCT00367003 History of Changes
Other Study ID Numbers:	IRB00024883
First Posted:	August 22, 2006
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