Deep Brain Stimulation for Refractory Major Depression

Inclusion Criteria:

• Age 30-70; men and women (non-pregnant)
• Diagnosis: major depressive episode (unipolar) by DSM-IV derived from the SCID-P.
• Recurrent disease; minimum 4 major depressive episodes .
• Chronic illness with current episode ~ 12 months duration
• Response failure to multiple treatment regimens. Resistance or intolerance to at least four treatments from different categories (SSRI, SNRI, TCA, HCA, MAOI, atypical, Lithium, anticonvulsants, ECT, VNS, CBT/IPT). Documentation of adequate dose and duration of each treatment.
• Hamilton Rating Scale for Depression (HRSD-24) score >20
• Global Assessment of Function. score ~50
• No neurological disease; no other Axis 1 or Axis II diagnosis; no substance abuse
• Stable on current antidepressant meditation regimen or medication free ~4 weeks
• Able to give informed consent in accordance with institutional policies.
• Able to comply with all testing and follow-up visit requirements defined by the Study Protocol. Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)

Exclusion Criteria:

• Atypical or psychotic subtypes of major depressive disorder.
• Alcohol or substance dependence within 12 months; abuse within 6 months, excluding nicotine Current suicidal ideations, plan or intent for self-harm; in past 3 years, repeated suicide attempts, resulting in emergency room or inpatient care.
• Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator.
• Likely to relocate or move to a location distant from the study site within one year of enrollment