Depression
Conditions
Keywords
Major Depression, Treatment Refractory Major Depression
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.
Interventions
DEVICEDeep Brain Stimulation with Medtronic Activa Neurostimulator
Deep brain stimulation (DBS) at 130 Hz
Sponsors
Medtronic
University Hospital, Bonn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HDRS) | analyzed at 12 and 24 month after stimulation onset |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | analyzed at 12 and 24 month after stimulation onset |
Countries
Germany
Outcome results
None listed