European Deep Brain Stimulation (DBS) Depression Study

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

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 treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.

The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.

Inclusion Criteria:

• Men and women (non-pregnant) age is 21-70 years;
• Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision, 2000 (DSM-IV-TR) criteria derived from the Mini International Neuropsychiatric Interview (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;
• Global Assessment of Functioning (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 Structured Clinical Interview for DSM-IV Personality Disorders (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;