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Deep Brain Stimulation for Treatment Resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00367003
First received: August 18, 2006
Last updated: May 29, 2014
Last verified: May 2014

August 18, 2006
May 29, 2014
September 2006
September 2014   (final data collection date for primary outcome measure)
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 ]
decrease in Hamilton Depression Rating Scale-24 score of less than or equal to 50% at 6 months open treatment
Complete list of historical versions of study NCT00367003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for Treatment Resistant Depression
Deep Brain Stimulation for Treatment Resistant Depression

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Device: Deep Brain Stimulator, implantable
Deep Brain Stimulator
Experimental: DBS for Treatment Resistant Depression
Deep Brain Stimulation for Treatment Resistant Depression.
Intervention: Device: Deep Brain Stimulator, implantable

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Sinead Quinn 404-727-9228 dbs@emory.edu
Contact: Morgan Woody, BA 404-712-1580 mswoody@emory.edu
United States
 
NCT00367003
IRB00024883
Yes
Helen Mayberg, Emory University
Emory University
The Dana Foundation
Principal Investigator: Helen Mayberg, M.D. Emory University
Emory University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP