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
  Purpose

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.


Condition Intervention Phase
Depression
Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Treatment-Refractory Major Depression

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: analyzed at 12 and 24 month after stimulation onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: analyzed at 12 and 24 month after stimulation onset ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2005
Study Completion Date: January 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator
Deep brain stimulation (DBS) at 130 Hz
Other Name: Activa Neurostimulator

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122031

Locations
Germany
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Medtronic
Investigators
Principal Investigator: Thomas E Schlaepfer, MD University of Bonn
Study Director: Volker Sturm, MD University of Cologne, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas E. Schlaepfer, MD, Professor of Psychiatry and Psychotherapy, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00122031     History of Changes
Other Study ID Numbers: BSG-04-006
Study First Received: July 15, 2005
Last Updated: June 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
Major Depression
Treatment Refractory Major Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014