A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression

Exclusion Criteria

• •1. A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria;
• •2. Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality.
• •3. 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;
• •4. Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
• •5. Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
• •6. Has been currently diagnosed with chronic fatigue syndrome;
• •7. Substantial suicidal risk as defined by (1) a current plan and intent, (2) clinician judgment that there is a clear immediate intent for self-harm, (3) more than 3 suicide attempts within the last 12 months;
• •8. Co-morbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI;
• •9. Alcohol, medication, or illegal substance dependence within last 12 months;
• •10. Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
• •11. Plans to use diathermy;
• •12. Have any metallic implants in the brain such as aneurysm clips or cochlear implants;
• •13. Currently participating in another investigational device, drug or surgical trial.