Deep Brain Stimulation for Treatment-Refractory Major Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Deep Brain Stimulation for Treatment-Refractory Major Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS<br> | Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator<br>* Deep brain stimulation (DBS) at 130 Hz<br>* Other names: Activa Neurostimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) |  | analyzed at 12 and 24 month after stimulation onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) |  | analyzed at 12 and 24 month after stimulation onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Treatment Refractory Major Depression