RESTORE-LIFE
Research type
Research Study
Full title
A Global PRospective, Multi-cEnter, ObServational post-markeT Study tO assess shoRt, mid and long-term Effectiveness and efficiency of VNS Therapy® as adjunctive therapy in reaL-world patIents with diFficult to treat dEpression.
IRAS ID
246304
Contact name
Renske De Zwaef
Contact email
Sponsor organisation
LIVANOVA Belgium N.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
RESTORE-LIFE is a prospective, observational, multi-site, global post-market study intended to assess short, mid, and long-term effectiveness and efficiency outcomes in “real-world” setting among patients with difficult to treat depression (such as patients with treatment resistant depression) treated with VNS Therapy as adjunctive therapy.
Currently there is no standard approach to the management of difficult to treat depression. This study will not only investigate the durability of the response of VNS in depression, but will also investigate the long-term disease management. In addition, the study will try to answer clinical and health economic questions in a real-world patient population with difficult to treat depression in different countries around the world.A minimum of 500 patients will be enrolled in up to 80 sites worldwide.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1001
Date of REC Opinion
13 Jun 2018
REC opinion
Further Information Favourable Opinion