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Deep Brain Stimulation for Treatment Resistant Depression

This study is currently recruiting participants.
Verified November 2017 by Helen Mayberg, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367003
First Posted: August 22, 2006
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
Helen Mayberg, Emory University
  Purpose
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 Intervention
Major Depressive Disorder Device: Deep Brain Stimulator, implantable

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Treatment Resistant Depression

Further study details as provided by Helen Mayberg, Emory University:

Primary Outcome Measures:
  • decrease in Hamilton Depression Rating Scale-24 score of at least 50% at 6 months open treatment [ Time Frame: 6 months ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: DBS for Treatment Resistant Depression
Deep Brain Stimulation for Treatment Resistant Depression.
Device: Deep Brain Stimulator, implantable
Deep Brain Stimulator

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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

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 Submitted: August 18, 2006
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