LivaNova launches VNS treatment-resistant depression trial

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 receiv...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Neuromodulation/Neurostimulation LivaNova Source Type: news