St. Jude Medical has received permission from the FDA to expand its study of deep brain stimulation as a treatment for major depressive disorder.
The FDA has approved the expansion of an ongoing clinical study of deep brain stimulation as a treatment for major depressive disorder (MDD). St. Jude Medical, a medical device company based in St. Paul, Minnesota, has been conducting the study at three sites with up to 50 patients and now has permission to expand it to 20 sites and up to 125 patients.
The study is testing the safety and effectiveness of the St. Jude Medical Libra, a device that is implanted in the patient’s head, where it delivers mild pulses of current to stimulate a part of the brain called Brodmann Area 25. The hope is that this stimulation will successfully relieve depression in patients for whom treatments such as medication, psychotherapy, and electroconvulsive therapy have proved ineffective.
To participate in the study, subjects must be between 21 and 70 years old, have been diagnosed with MDD, have had their first depressive episode before the age of 45, and have tried at least four other treatments for their current depressive episode.
A preceding pilot study found that after six months of treatment with the device, 62% of patients had at least a 40% decrease in symptoms of depression according to the Hamilton Rating Scale for Depression and 92% maintained their improvement after their final follow-up visit, usually around a year later. St. Jude Medical hopes to expand the current study to 231 patients at a later date.
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St. Jude Medical Receives FDA Approval for Expansion of BROADEN Deep Brain Stimulation Study for Depression [St. Jude Medical Press Release]