Assessing safety and efficacy of Vortioxetine versus SSRIs in elderly patients with depression: a pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial (Version 3, 05/12/16). VESPA study: Vortioxetine in the Elderly vs. SSRIs: a Pragmatic Assessment. Codice 2016-0234923 – Bando AIFA 2016

Starting date
February 13, 2018
Duration (months)
36
Departments
Neurosciences, Biomedicine and Movement Sciences
Managers or local contacts
Barbui Corrado

Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. This condition has also indirect costs related to the psychological and economic burden on family members, caregivers, and the wider society. SSRIs are the most commonly prescribed agents in elderly depressed patients and, although generally safe, they may be associated with tolerability issues. Vortioxetine is an antidepressants with a novel mechanism of action. Based on available studies, this drug has a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, wakefulness, body weight, and electrocardiogram parameters.
 
Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine compared with the SSRIs as a group (including sertraline, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The primary outcome will be the withdrawal rate due to adverse events. Secondary outcomes will include: mortality, suicide, self-harm, occurrence of any adverse event, falls, bleeding, hyponatraemia, QTc prolongation. Validated rating scales will be administer by blind staff to assess efficacy and quality of life.
 

Sponsors:

AIFA Agenzia Italiana del Farmaco
Funds: assigned and managed by the department

Project participants

Corrado Barbui
Full Professor

Collaboratori esterni

Eugenio Aguglia
Università di Catania, AOU Policlinico Vittorio-Emanuele
Alessandro Rodolico
Università di Catania, AOU Policlinico Vittorio-Emanuele
Pasquale De Fazio
AOU Mater Domini, Università Magna Grecia - Catanzaro
Giovanni Martinotti
Università di Chieti
Luigi Grassi
Università di Ferrara
Andrea Aguglia
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
Rita Roncone
Università degli Studi dell’Aquila
Armando D'Agostino
Polo Universitario San Paolo, ASST Santi Paolo e Carlo - Milano
Giuseppe Carra'
Università San Gerardo - Monza
Massimo Biondi
La Sapienza Università di Roma
Claudio Lucii
ULS7 Siena
Vilma Xocco
ASL TO1-Mauriziano - Torino
Camilla Callegari
Ospedale di Circolo Varese
Angelo Barbato
IRCCS Mario Negri - Milano

Activities

Research facilities