People suffering from depression frequently don’t respond well to treatment. As many as two thirds of patients report that the first antidepressant they try is ineffective, according to WebMD. And as many as one third of patients don’t respond to multiple attempts to treat them.
A recent, small study at Emory University indicated that deep-brain stimulation (DBS) could help patients with severe depression that is resistant to treatment. Following up on that, a nationwide randomized clinical research study will investigate the use of DBS in patients with major depression.
Dubbed the “BROADEN” study, which is an abbreviation of sorts for “BROdmann Area 25 DEep brain Neuromodulation,” it will investigate the use of DBS in patients diagnosed with treatment-resistant unipolar major depressive disorder.
In this St. Jude-sponsored study, DBS will be used to deliver mild pulses of current to the Brodmann Area 25 of the brain, which appears to be overactive in patients with major depression.
Patients in the 14-month study will receive a neurosurgically-implanted DBS device and will have the option to participate in a long-term follow-up study while continuing with DBS programming-related care with a BROADEN study center. Alternatively, they’ll have the option to have the DBS device removed.
From the press release:
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 study is being conducted under an FDA investigational device exemption.
Press release: Vanderbilt To Study Deep Brain Stimulation For Depression…
More information on the study is available at www.BroadenStudy.com.
