Surgical Procedure Is an Additional Tool for Some Cases of Treatment-resistant Depression

Cedars-Sinai Medical Center is among the first centers in Southern California to begin offering vagus nerve stimulator (VNS) implantation as a potential supplement to traditional therapies for treatment-resistant depression. The device, used in epilepsy treatment for nine years, was approved by the Food and Drug Administration (FDA) last year for treating depression.

"Cedars-Sinai psychologists and psychiatrists are available to consult with patients and treatment professionals in the community, provide evaluations and screenings, and refer appropriate candidates to the neurosurgeons for surgical intervention," said Keith L. Black, M.D., director of the Division of Neurosurgery. "Psychiatrists will program and monitor the stimulators to provide ongoing management of VNS as one element of the treatment plan."

Implantation of the stimulator is an outpatient operation that takes only about 45 minutes. Two incisions are made – one in the neck, beside the Adam's apple, and the other in the chest.

An electrode is wrapped around the vagus nerve in the neck, and a pulse generator, which is similar to a heart pacemaker, is implanted in the chest. With the wires connecting the two components tunneled under the skin, there are no external, visible parts.

Once the patient's incisions have healed, the device is turned on, sending intermittent, preprogrammed, mild electrical pulses through the vagus nerve into the brain. Although results are not immediate and many patients do not respond at all, a significant number eventually feel relief.

"This is a new treatment modality that may help about one in three people with very severe depression," said Mark H. Rapaport, M.D., chairman of Cedars-Sinai's Department of Psychiatry, noting that studies are underway to determine if there are predictors that will help psychiatrists identify which patients are most likely to have a good response. "When you consider that chronic, severe depression is associated with both increased morbidity and increased mortality, giving somebody a one in three chance of feeling a lot better is a considerable improvement, and it is a hope we can offer."

Rapaport participated in a major clinical trial that led to the FDA's decision to approve VNS for depression. In that study, half of the patients undergoing VNS implantation had the device turned on two weeks after surgery. The other half had the device implanted but not turned on immediately. Patients were not informed which group they were in, and at three months, there was little discernable difference between the two groups. In fact, a difference was evident only on the more sensitive of two inventories used to evaluate depression.

But at the three-month point, the second group's devices were turned on, with other appropriate medications and therapies continuing as usual. And at one year post-surgery, members of both groups were compared to patients who had qualified to participate in the study but did not undergo the operation.