St. Jude Medical, Inc. announced in a press release on February 7th that it had received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in a controlled, multi-site, blinded, clinical study of deep brain stimulation (DBS) for major depressive disorder.
The new study, called the BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) study, will build upon the work of neurologist Helen S. Mayberg, M.D. and neurosurgeon Andres Lozano, M.D. who reported in the March 2005 issue of Neuron that they had found that an area in the brain called Brodmann Area 25 appears to be overactive when depressed. The study will evaluate the safety and effectiveness of using DBS to stimulate the Brodmann Area 25 in patients with treatment-resistant depression.
The study is significant because, out of the more than 21 million adults who suffer from depression, only about 80 percent can be effectively treated with currently available therapies, leaving 4 million Americans living with untreatable depression. DBS could offer hope to these patients.
St. Jude Medical owns the intellectual property rights and has several patents pending for the use of neurostimulation at Brodmann Area 25. The Libra® Deep Brain Stimulation System, which is being evaluated in the current study, is designed to deliver mild electrical pulses from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.
To be eligible for the study, participants must:
- Currently be diagnosed with major depressive disorder
- Be between 21 and 70 years old, with onset of first episode before age 45
- Have tried at least four treatments in their current episode, such as different medications, various combinations of medications or electroconvulsive therapy
- Have been depressed for at least one year
For more information about this study, call toll-free 866-787-4332 or visit http://www.BROADENstudy.com.
