Trial record 6 of 72 for:    deep brain stimulation depression

Deep Brain Stimulation for Treatment-Refractory Major Depression

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas E. Schlaepfer, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00122031
First received: July 15, 2005
Last updated: June 13, 2012
Last verified: June 2012

July 15, 2005
June 13, 2012
July 2005
April 2009   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: analyzed at 12 and 24 month after stimulation onset ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00122031 on ClinicalTrials.gov Archive Site
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: analyzed at 12 and 24 month after stimulation onset ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for Treatment-Refractory Major Depression
Deep Brain Stimulation for Treatment-Refractory Major Depression

This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.

Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major depression.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator
Deep brain stimulation (DBS) at 130 Hz
Other Name: Activa Neurostimulator
Experimental: DBS
Intervention: Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2011
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Major depression (MD), severe, unipolar type
  • German mother tongue
  • Hamilton Depression Rating Scale (HDRS24) score of > 20
  • Global Assessment of Function (GAF) score of < 45
  • At least 4 episodes of MD or chronic episode > 2 years
  • > 5 years after first episode of MD
  • Failure to respond to *adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;

    • adequate trials (>3 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant); *an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and; *an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
  • Able to give written informed consent
  • No medical comorbidity
  • Drug free or on stable drug regimen at least 6 weeks before study entry

Exclusion Criteria:

  • Current or past nonaffective psychotic disorder
  • Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
  • Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
  • Any surgical contraindications to undergoing DBS
  • Current or unstably remitted substance abuse (aside from nicotine)
  • Pregnancy and women of childbearing age not using effective contraception
  • History of severe personality disorder
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00122031
BSG-04-006
No
Thomas E. Schlaepfer, MD, University Hospital, Bonn
University Hospital, Bonn
Medtronic
Principal Investigator: Thomas E Schlaepfer, MD University of Bonn
Study Director: Volker Sturm, MD University of Cologne, Germany
University Hospital, Bonn
June 2012

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