Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S

Prior treatment

• Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder
• Participation in another drug, device or biologics trial within the preceding 30 days prior to initial screening

Other illness

• 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
• Evidence of global cognitive impairment
• General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices)
• History of intolerance to neural stimulation of any area of the body
• Conditions requiring repeated MRI scans
• Conditions requiring diathermy
• Conditions requiring anticoagulant medication
• Terminal illness associated with expected survival of \<12 months

Other

• 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
• Current psychotic symptoms
• 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
• Inability or unwillingness to comply with long-term follow-up

• 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