Deep Brain Stimulation for Treatment-Refractory Major Depression
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- University Hospital, Bonn
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Rating Scale (HDRS)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Thomas E. Schlaepfer, MD
Professor of Psychiatry and Psychotherapy
University Hospital, Bonn
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
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
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale (HDRS)
Time Frame: analyzed at 12 and 24 month after stimulation onset
Secondary Outcomes
- Montgomery-Asberg Depression Rating Scale (MADRS)(analyzed at 12 and 24 month after stimulation onset)