LivaNova (NSDQ:LIVN) said yesterday it launched a new trial of its VNS therapy system exploring its use treating patients with treatment-resistant depression and that it enrolled the first patient in the trial.
The first patient in the trial was enrolled by Karl-Jürgen Bär of Germany’s Universitätsklinikum Jena, the London-based company said.
“Treatment-resistant depression, or difficult-to-treat depression, is an area of mental health in need of additional proven treatment options. Up to one-third of patients suffering from depression do not respond to several attempts at treatment. This real-world study will help further define the near- and long-term benefits of VNS Therapy as an adjunctive treatment within this patient population,” Bär said in a prepared statement.
In the study, researchers plan to enroll 500 patients to explore the use of the VNS system to treat patients with treatment-resistant depression who have failed to achieve an adequate response to standard psychiatric management across a minimum of three and maximum of five years.
The primary endpoint of the trial is response at one year and defined as a reduction in total score on the Montgomery Åsberg Depression Rating Scale of at least 50% from the patient’s baseline score. Secondary endpoints will include factors such as quality of life, patient function, health care utilization and adjunctive antidepressant treatments, LivaNova said.
LivaNova’s VNS Therapy system received CE Mark approval in the European Union in 2001 and FDA approval in 2005, and consists of a programmable electronic pulse generator connected to a bipolar electrical lead which sends pulses to simulate the vagus nerve.
“This post-market study will allow us to have a better understanding of this treatment-resistant patient population and the significant role VNS Therapy can play in the overall management of this disease. Restore-Life is unique in the fact that clinical response, patient functioning and resource utilization will be followed up globally for five years, amassing high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for difficult-to-treat depression,” clinical, regulatory & quality VP Bryan Olin said in a press release.