Cyberonics enrolls patients in treatment-resistant depression study

By Elaine Rigoli

Tampa, Fla., May 17 - Cyberonics, Inc. announced that the first nine patients have been enrolled in a year-long vagus nerve stimulation therapy dosing study that will examine treatment outcomes for patients with treatment-resistant depression who are randomized to three different doses of vagus therapy.

About 460 patients at 30 study sites will be enrolled in the multi-center, double-blind, randomized study, and each patient will participate in the study for 54 weeks.

In July 2005, the Food and Drug Administration approved vagus nerve stimulation therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments, the company said in a news release.

The FDA also approved it as an adjunctive therapy to reduce the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications, the release said.

Based in Houston, Cyberonics develops medical devices for the long-term treatment of epilepsy and other chronic neurological disorders.

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