BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) is the first randomized clinical research study to investigate DBS as an intervention for patients diagnosed with unipolar major depressive disorder (excluding bipolar disorder) who have not improved after multiple treatments.
DBS is a therapy that uses mild pulses of current (stimulation) to regulate specific areas of the brain, much like a pacemaker uses pulses of current to regulate the heart.
In this study, stimulation is being delivered to an area of the brain known as Brodmann Area 25, which is believed to function differently in people with major depression and appears to be overactive when people are profoundly sad and depressed.
Vanderbilt was chosen to participate in this study, which builds on the work of a research team from the University of Toronto led by Helen S. Mayberg and Andres Lozano, because of its extensive experience with various forms of neuromodulation and in treating psychiatric illness.
Ronald Salomon, M.D., associate professor of Psychiatry, is the principal investigator for the study at Vanderbilt, working with Joseph Neimat, M.D., assistant professor of Neurological Surgery, the co-investigator and neurosurgeon responsible for performing the DBS implantation procedure.
Patients enrolling in the study must be willing to transfer psychiatric care to Dr. Salomon during the course of the 14-month study.
Once the study has been completed, patients will have the option to either participate in a long-term follow-up study, return to the care of their referral psychiatrist while maintaining DBS programming-related care with a BROADEN study center, or have the DBS system removed.
The study sponsor is providing the investigational study device and study-related care at no charge to enrolled patients.
Participants must be between 21 and 70 years old, with the onset of the first episode before age 45, and currently be diagnosed with major depressive disorder.
Other criteria include being depressed for at least one year in their current episode, having tried at least four treatments in their current episode, and having tried a course of psychotherapy for depression at least once.
Participants cannot have met criteria for borderline or antisocial personality disorder in the last 12 months, cannot have GAD (Generalized Anxiety Disorder) as a primary diagnosis during the current episode, cannot have co-morbid OCD (Obsessive-Compulsive Disorder), PTSD (Post-traumatic Stress Disorder), panic disorder, or eating disorder (unless in remission for 6 months), and cannot have been diagnosed with schizophrenia, schizoaffective disorder, or other lifetime psychotic disorders.
The BROADEN study is sponsored by St. Jude Medical and is being conducted under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE). BROADEN is a trademark of Advanced Neuromodulation Systems doing business as St. Jude Medical Neuromodulation Division.
For more information about the study, please call toll-free 877-796-8732 or visit www.BroadenStudy.com.
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