Deep Brain Stimulation for Treatment-Refractory Major Depression

Depression Clinical Trial

Official title:

Deep Brain Stimulation for Treatment-Refractory Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122031
• Other study ID #: BSG-04-006
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2005
• Last updated: June 13, 2012
• Start date: July 2005
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Device:
• Deep Brain Stimulation with Medtronic Activa Neurostimulator
Deep brain stimulation (DBS) at 130 Hz

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Medtronic

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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 anxiet — View 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. Ep — View 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. — View 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. Epub 2006 Sep 8. — View 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. — View 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. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS)		analyzed at 12 and 24 month after stimulation onset	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)		analyzed at 12 and 24 month after stimulation onset	No