Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

Prior treatment

• Any previous surgery to destroy the region of the brain that will be the target of treatment.
• Participation in another drug, device, or biologics trial within the preceding 30 days
• Subject is on anticoagulant medication.

Other illness

• Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis.
• Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
• Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
• History of stimulation intolerance in any area of the body.
• History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder.
• Presence of a condition requiring routine MRIs.
• Presence of a condition requiring diathermy.
• Terminal illness associated with expected survival of \<12 months.

Age

• Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required.

Other

• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Refusal of an adequate trial of ECT.
• Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.
• Imminent risk of suicide
• Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).

• Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-IV (SCID I/DSM-IV), judged to be of disabling severity.
• Age 22 - 70 years.
• 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items
• Global Assessment of Function (GAF) score of 45 or less.
• A recurrent (equal or \>4 episodes) or chronic (episode duration equal or higher \>2 years) course AND a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior).
• Failure to respond to: 6.1. Adequate trials (equal or \>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND; 6.2. adequate trials ( equal\>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND; 6.3 An adequate trial of ECT (\>6 bilateral treatments), or inability to tolerate an adequate ECT trial, AND; 6.4 An adequate trial of individual psychotherapy (\>20 sessions with an experienced psychotherapist).
• Able to comply with the operational and administrative requirements of participation in the study.
• Able to give written informed consent
• On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study.
• Good general health. No changes in medication treatment during participation in study.