European Deep Brain Stimulation (DBS) Depression Study

Study Overview
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Brief Summary
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To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD, single or recurrent episode on mood as measured by the MADRS.

Official Title
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A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Device: Deep Brain Stimulation
* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (non-pregnant) age is 21-70 years; Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria derived from the MINI; First episode onset before age 45; Current episode > 12 month duration; In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories; In adult lifetime (>21 year of age) have experience a period of wellness as defined by DSM IV criteria; MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists; GAF score <50; Mini-mental state examination (MMSE) score >24; No change in current antidepressant medication regimen or medication free for at least 4 weeks prior to study entry; Able to give informed consent in accordance with institutional policies; Exclusion Criteria: A diagnosis of bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI; Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, preferably screened via SCID-II at Baseline visit (optional); In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>Low Programming | Device: Deep Brain Stimulation<br>* Low Programming<br>* Other names: Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division);|
| Experimental: Group A<br>Normal Programming | Device: Deep Brain Stimulation<br>* Normal DBS Programming<br>* Other names: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change from mean baseline values in MADRS score |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change from baseline value of HDRS |  | 3, 6, 9, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Unipolar, Implantable Stimulation Electrodes