Northstar Neuroscience, a medical device company, has announced that the FDA has granted conditional approval of a second clinical study of its Renova cortical stimulation system for the treatment of major depressive disorder.
With this approval, the company expects to begin enrolling patients into its Prospect II study this quarter, with preliminary results anticipated during the second half of 2009.
The Prospect II study is a prospective, double-blinded, sham-controlled study designed to build on the positive safety profile and promising efficacy observed in the Prospect I feasibility trial. The trial will be conducted at up to six investigational sites and will include up to 24 subjects.
John Bowers, president and CEO of Northstar Neuroscience, said: "Targeted stimulation of the cerebral cortex has shown promise in relieving depressive symptoms where drugs and other therapies have not been effective. This is an important milestone for our depression program, and we are excited to move forward with our clinical collaborators to begin study enrollment."
Brian Kopell, Northstar's vice president of medical affairs, said: "Cortical stimulation represents a new approach to treat depression. Increasing evidence points to disordered neural networks in the brain as an underlying cause of depressive symptoms. We believe that we can influence these networks with electrical stimulation without placing electrodes deep within brain tissue. This technology has the potential to offer an alternative treatment to many desperate individuals who currently have exhausted conventional options for the treatment of major depressive disorder."