Friday, April 10, 2009

FDA Approves Pioneering Treatment for Obsessive- Compulsive Disorder

Psychiatrists will have to take the lead in ensuring that deep-brain stimulation (DBS)—approved by the FDA in February for the first time for use in obsessive-compulsive disorder (OCD)—is used appropriately.

Medtronic Inc’s Reclaim DBS therapy was approved under a humanitarian device exemption, which means that the system will be used on a relatively small number of adults (no more than 4000 and probably considerably fewer) with recalcitrant OCD.

The DBS device offers an adjustable, reversible, and nondrug therapy. This surgically implanted device- similar to a pacemaker- delivers carefully controlled electrical pulses to precisely targeted areas of the brain.

Only one other medical device has been approved for treatment of a psychiatric condition: the vagus nerve stimulation (VNS) implantation device made by Cyberonics. In 1997, the FDA approved the use of VNS as an adjunctive therapy for partialonset epilepsy; in 2005, its use in treatment-resistant depression was also approved. But Benjamin D. Greenberg, MD, PhD, told Psychiatric Times that VNS has been somewhat controversial, and insurance reimbursement remains an issue. Greenberg, who is associate professor of psychiatry at Brown University Medical School in Providence, RI, noted, however, that VNS does not involve brain surgery, as DBS does. Thus, the potential adverse effects from DBS, while relatively rare, can be more serious.