European Deep Brain Stimulation (DBS) Depression Study

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Unipolar, Implantable Stimulation Electrodes Read More

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;