St Jude Medical announced on 11 July that the US FDA has granted approval for expansion of its BROADEN (Brodmann area 25 deep brain neurostimulation) study for depression. This expansion will allow a maximum of 20 sites across the USA to enroll up to 125 patients.
The BROADEN study is investigating whether or not stimulating an area of the brain known as Brodmann Area 25 (BA25) with a deep brain stimulation system is a safe and effective method for treating severe depression.
“Deep brain stimulation could potentially change the way that we look at treating patients suffering with severe depression,” said Mark George, distinguished professor of psychiatry, radiology and neurology at the Medical University of South Carolina. “Treatments such as medications, psychotherapy and electroconvulsive therapy often fail to work for these very difficult-to-treat patients, so we are hopeful this research will provide us with a new approach to treating this debilitating condition.”
The BROADEN study is a controlled, blinded study that utilises the St Jude Libra deep brain stimulation system. Prior to the expansion, this study was conducted at only three centres located in Chicago, New York City and Dallas. Participants need to be classified as having treatment-resistant depression and must have failed multiple treatments to be candidates taking part in the study.
“We are committed to leading this important research in hopes of finding a solution for people who currently do not have a treatment option,” said Chris Chavez, president of the St Jude Medical Neuromodulation Division. “By expanding the BROADEN study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder.”
The BROADEN study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). The study builds upon an earlier St Jude Medical pilot study which reported that at six months, 62% of the patients experienced at least a 40% decrease in symptoms of depression as measured by a standardised test called the Hamilton Rating Scale for Depression. Of these patients, 92% maintained this improvement at their last follow-up visit (typically at one year).