St. Jude Medical, Inc. today announced pilot study results from the first multi-center study investigating deep brain stimulation (DBS) of Brodmann Area 25 for major depressive disorder.
Results of the study, which were presented today at the American Psychiatric Association (APA) meeting in Washington, D.C., found that 6 months after the procedure, 56 percent of the patients experienced at least a 40 percent decrease in depressive symptoms. Patient's symptoms were measured using a standardized test called the Hamilton Rating Scale for Depression.
Results were presented by Sidney Kennedy, M.D., psychiatrist-in-chief with the University Health Network in Toronto. "Severe depression destroys a person's ability to be productive and have a normal quality of life," said Dr. Kennedy. "The results from this study are very promising, and we are hopeful that our research will lead to a therapy that can help these patients."
Prior to beginning the study, all patients were classified as having severe depression after multiple treatments - such as medications, psychotherapy and electroconvulsive therapy - had failed to provide sustained relief from depression. Each study patient had tried a minimum of 12 depression medications over his or her lifetime.
DBS was targeted at an area of the brain known as Brodmann Area 25, which appears to become overactive when people are profoundly sad and depressed. Conducted at three leading Canadian academic medical centers, the study expands and supports the groundbreaking research of Helen Mayberg, M.D., and Andres Lozano, M.D., which was published in Neuron in March 2005.
On average, the 20 study participants had suffered from depression for more than 20 years; they were disabled and unable to work at the time of enrollment. The study also found that:
- At their most recent psychiatric evaluation, 78 percent of the patients experienced at least a 40 percent decrease in depressive symptoms.
- Three of the study patients are considered to be in remission.
- Eight patients have re-engaged in life activities such as work, school, relationships and travel.
In the study, DBS was delivered through the St. Jude Medical Libra® Deep Brain Stimulation System, which delivers mild electrical current from a device implanted near the collarbone; the device is connected to small electrical leads placed at specific targets in the brain.
"These results are important as they help establish the body of evidence that will continue to move depression research forward," said Chris Chavez, president of the St. Jude Medical ANS Division. "We are committed to leading the development of products that can make life better for patients suffering from this debilitating condition."
Based on the results of this research, St. Jude Medical announced the BROADEN™ (BROdmann Area 25 DEep brain Neuromodulation) study in February 2008, to further investigate the use of DBS for major depressive disorder. A controlled, multi-center, blinded clinical study, BROADEN is being conducted in the U.S. under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).