Magazine article Clinical Psychiatry News

Support Wavers for Brain Stimulation

Magazine article Clinical Psychiatry News

Support Wavers for Brain Stimulation

Article excerpt

RANCHO MIRAGE, CALIF. -- Two of the newer brain stimulation treatments for chronic depression took hits from the federal government in recent actions, Dr. William McDonald said at the annual meeting of the American College of Psychiatrists.

As a result, vagal nerve stimulation (VNS) may become less available, and it's unlikely that transcranial magnetic stimulation (TMS) will be approved any time soon, said Dr. McDonald, J.B. Fuqua Professor of Psychiatry and Behavioral Sciences at Emory University in Atlanta.

The Centers for Medicare and Medicaid Services is reconsidering whether to continue covering the cost of VNS, which was approved for treatment of chronic depression in a controversial decision by the Food and Drug Administration in 2005, he said.

The data backing use of VNS were not very strong. An open committee of the FDA recommended against approval, but the device was approved in a closed committee with the contingency that the device's maker conduct follow-up studies of safety and efficacy, said Dr. McDonald, a consultant and speaker for Cyberonics, which markets the VNS device, and for NeuroNetics, manufacturer of the TMS machine.

"If Medicare doesn't pay for VNS, it's unclear who will pay for it," he said. So far, all of the patients treated with VNS at his institution have been either young and disabled or older patients who were insured under Medicare.

Although initial open-label pilot data made VNS look promising, the primary outcomes of a subsequent randomized, placebo-controlled study of 235 patients "were nothing but disappointing," he said. After 8 weeks of treatment, there was no significant difference in response rates measured by the Hamilton Rating Scale for Depression ([HRSD.sub.24]) in the VNS group compared with patients randomized to sham treatment.

There was a significant difference, however, in a secondary measure of outcome. …

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