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Inclusion Criteria:

* Ability to provide written informed consent.
* Agrees to relocate to the Atlanta Metro region for the duration of the acute phase of the investigation (approximately 8-10 months) and to return regularly for clinical and research assessments
* Current Major Depressive Episode (MDE), either Major Depressive Disorder single episode or recurrent type
* Current depressive episode of at least two years duration or a history of more than 4 lifetime depressive episodes
* Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17)
* Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score
* A maximum Global Assessment of Functioning of 50 or less
* Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different drug classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode
* Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode
* On stable antidepressant medication
* Have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist

Exclusion Criteria:

* Inability/ refusal to sign written informed consent
* Refusal or inability to relocate to Atlanta Metro region for acute phase of protocol or to return for regular assessments in long term follow up
* Inability to tolerate general anesthesia
* Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder
* Other currently active clinically significant Axis I psychiatric diagnosis including bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder
* Current psychotic symptoms
* Evidence of global cognitive impairment
* Substance abuse or dependence not in full, sustained remission
* Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years
* Pregnancy or plan to become pregnant during the study period
* General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices)
* Inability or unwillingness to comply with long-term follow-up
* History of intolerance to neural stimulation of any area of the body
* Participation in another drug, device or biologics trial within the preceding 30 days prior to initial screening
* Conditions requiring repeated MRI scans
* Conditions requiring diathermy
* Conditions requiring anticoagulant medication
* Terminal illness associated with expected survival of \<12 months

• Atlanta, Georgia, United States