TY - JOUR
T1 - Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study
T2 - a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial
AU - Ostuzzi, Giovanni
AU - Gastaldon, Chiara
AU - Barbato, Angelo
AU - D'Avanzo, Barbara
AU - Tettamanti, Mauro
AU - Monti, Igor
AU - Aguglia, Andrea
AU - Aguglia, Eugenio
AU - Alessi, Maria Chiara
AU - Amore, Mario
AU - Bartoli, Francesco
AU - Biondi, Massimo
AU - Bortolaso, Paola
AU - Callegari, Camilla
AU - Carrà, Giuseppe
AU - Caruso, Rosangela
AU - Cavallotti, Simone
AU - Crocamo, Cristina
AU - D'Agostino, Armando
AU - De Fazio, Pasquale
AU - Di Natale, Chiara
AU - Giusti, Laura
AU - Grassi, Luigi
AU - Martinotti, Giovanni
AU - Nosé, Michela
AU - Papola, Davide
AU - Purgato, Marianna
AU - Rodolico, Alessandro
AU - Roncone, Rita
AU - Tarsitani, Lorenzo
AU - Turrini, Giulia
AU - Zanini, Elisa
AU - Amaddeo, Francesco
AU - Ruggeri, Mirella
AU - Barbui, Corrado
PY - 2020/8/3
Y1 - 2020/8/3
N2 - INTRODUCTION: Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome.METHODS AND ANALYSIS: This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled.ETHICS AND DISSEMINATION: This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants' data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.TRIAL REGISTRATION: Clinicaltrials.gov: NCT03779789 , Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018-001444-66.TRIAL STATUS: Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.
AB - INTRODUCTION: Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome.METHODS AND ANALYSIS: This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled.ETHICS AND DISSEMINATION: This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants' data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.TRIAL REGISTRATION: Clinicaltrials.gov: NCT03779789 , Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018-001444-66.TRIAL STATUS: Protocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.
U2 - 10.1186/s13063-020-04460-6
DO - 10.1186/s13063-020-04460-6
M3 - Article
C2 - 32746941
VL - 21
SP - 695
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
ER -