NCT00122031

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 depression

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3.8 years

First QC Date

July 15, 2005

Last Update Submit

June 13, 2012

Conditions

Depression

Keywords

Major DepressionTreatment Refractory Major Depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (HDRS)

    analyzed at 12 and 24 month after stimulation onset

Secondary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    analyzed at 12 and 24 month after stimulation onset

Study Arms (1)

DBS

EXPERIMENTAL
Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator

Interventions

Deep Brain Stimulation with Medtronic Activa NeurostimulatorDEVICE

Deep brain stimulation (DBS) at 130 Hz

Also known as: Activa Neurostimulator
DBS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Bonn

Bonn, 53105, Germany

Location

Related Publications (7)

  • Cohen MX, Axmacher N, Lenartz D, Elger CE, Sturm V, Schlaepfer TE. Good vibrations: cross-frequency coupling in the human nucleus accumbens during reward processing. J Cogn Neurosci. 2009 May;21(5):875-89. doi: 10.1162/jocn.2009.21062.

    PMID: 18702577BACKGROUND

  • Lieb K, Schlaepfer TE. Deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Nov 23;355(21):2256; author reply 2256. doi: 10.1056/NEJMc062545. No abstract available.

    PMID: 17124028BACKGROUND

  • Kosel M, Sturm V, Frick C, Lenartz D, Zeidler G, Brodesser D, Schlaepfer TE. Mood improvement after deep brain stimulation of the internal globus pallidus for tardive dyskinesia in a patient suffering from major depression. J Psychiatr Res. 2007 Nov;41(9):801-3. doi: 10.1016/j.jpsychires.2006.07.010. Epub 2006 Sep 8.

    PMID: 16962613BACKGROUND

  • Schlaepfer TE, Cohen MX, Frick C, Kosel M, Brodesser D, Axmacher N, Joe AY, Kreft M, Lenartz D, Sturm V. Deep brain stimulation to reward circuitry alleviates anhedonia in refractory major depression. Neuropsychopharmacology. 2008 Jan;33(2):368-77. doi: 10.1038/sj.npp.1301408. Epub 2007 Apr 11.

    PMID: 17429407RESULT

  • Bewernick BH, Hurlemann R, Matusch A, Kayser S, Grubert C, Hadrysiewicz B, Axmacher N, Lemke M, Cooper-Mahkorn D, Cohen MX, Brockmann H, Lenartz D, Sturm V, Schlaepfer TE. Nucleus accumbens deep brain stimulation decreases ratings of depression and anxiety in treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):110-6. doi: 10.1016/j.biopsych.2009.09.013.

    PMID: 19914605RESULT

  • Bewernick BH, Kayser S, Sturm V, Schlaepfer TE. Long-term effects of nucleus accumbens deep brain stimulation in treatment-resistant depression: evidence for sustained efficacy. Neuropsychopharmacology. 2012 Aug;37(9):1975-85. doi: 10.1038/npp.2012.44. Epub 2012 Apr 4.

    PMID: 22473055RESULT

  • Grubert C, Hurlemann R, Bewernick BH, Kayser S, Hadrysiewicz B, Axmacher N, Sturm V, Schlaepfer TE. Neuropsychological safety of nucleus accumbens deep brain stimulation for major depression: effects of 12-month stimulation. World J Biol Psychiatry. 2011 Oct;12(7):516-27. doi: 10.3109/15622975.2011.583940. Epub 2011 Jul 8.

    PMID: 21736514DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Thomas E Schlaepfer, MD

    University of Bonn

    PRINCIPAL INVESTIGATOR

  • Volker Sturm, MD

    University of Cologne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychotherapy

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Primary Completion

April 1, 2009

Study Completion

January 1, 2011

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

DE(1)