LivaNova (NSDQ:LIVN) today announced the publication of a new study that showed adding vagus nerve stimulation (VNS) therapy to treatment-as-usual significantly improves outcomes in patients with treatment-resistant bipolar depression (TRBD).
Published in the International Journal of Bipolar Disorders, the study examined patients from a 5-year prospective registry and found 63% of 97 patients treated with VNS plus treatment-as-usual had a significant reduction in depressive symptoms, as measured by a 50% or greater reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS), compared with 39% of the 59 patients in the standard treatment alone group.
Patients who received adjunctive VNS therapy also responded more quickly and experienced more durable antidepressant effects. The study concluded that adjunctive VNS therapy is an efficacious antidepressant treatment for patients with treatment-resistant bipolar depression.
“Given the significant unmet need with regard to the management of bipolar depression patients, it is critical that alternative treatment options for patients with TRBD are explored,” said Dr. A. John Rush, adjunct professor at the Departments of Psychiatry, Duke University Medical School and Texas Tech University, in a news release. “This study’s findings that adjunctive use of VNS therapy can significantly improve depressive symptoms and reduce suicidal ideation while also increasing the durability of antidepressant effect, promises to transform the lives of patients with difficult-to-treat bipolar depression for the better.”
Before treatment, subjects in the adjunctive VNS therapy group had, on average, suffered from 20.7 lifetime episodes of depression, had approximately three lifetime suicide events and had been treated with nine different therapies, including an antidepressant at some point, LivaNova noted. In comparison to the treatment-as-usual group and before the study, patients in the adjunctive VNS group had experienced more episodes of depression, psychiatric hospitalizations, lifetime suicide attempts, along with a higher suicidality score and more severe symptoms based on MADRS and other scales at baseline, the company added.
“LivaNova is dedicated to helping patients who suffer from treatment-resistant bipolar depression,” said Bryan Olin, SVP for clinical, quality and regulatory affairs at London-based LivaNova. “We are heartened to see that the results of this five-year study show that patients receiving adjunctive VNS therapy were more likely to respond and experienced a faster and more durable response than patients treated with TAU alone. Moreover, the study reconfirmed that adjunctive VNS therapy significantly lowers suicidality, a very important and key factor when considering the overall positive impact on the lives of patients and their loved ones.”