search
Back to results

Deep Brain Stimulation for Treatment-Refractory Major Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Deep Brain Stimulation with Medtronic Activa Neurostimulator
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depression, Treatment Refractory Major Depression

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Bonn

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)

Full Information

First Posted
July 15, 2005
Last Updated
June 13, 2012
Sponsor
University Hospital, Bonn
Collaborators
Medtronic
search

1. Study Identification

Unique Protocol Identification Number
NCT00122031
Brief Title
Deep Brain Stimulation for Treatment-Refractory Major Depression
Official Title
Deep Brain Stimulation for Treatment-Refractory Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depression, Treatment Refractory Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation with Medtronic Activa Neurostimulator
Other Intervention Name(s)
Activa Neurostimulator
Intervention Description
Deep brain stimulation (DBS) at 130 Hz
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Time Frame
analyzed at 12 and 24 month after stimulation onset
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
analyzed at 12 and 24 month after stimulation onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E Schlaepfer, MD
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volker Sturm, MD
Organizational Affiliation
University of Cologne
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18702577
Citation
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.
Results Reference
background
PubMed Identifier
17124028
Citation
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.
Results Reference
background
PubMed Identifier
16962613
Citation
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.
Results Reference
background
PubMed Identifier
17429407
Citation
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.
Results Reference
result
PubMed Identifier
19914605
Citation
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.
Results Reference
result
PubMed Identifier
22473055
Citation
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.
Results Reference
result
PubMed Identifier
21736514
Citation
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.
Results Reference
derived

Learn more about this trial

Deep Brain Stimulation for Treatment-Refractory Major Depression

We'll reach out to this number within 24 hrs