Clinical Research Directory

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