Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial
Giovanni Ostuzzi,
Chiara Gastaldon,
Angelo Barbato,
Barbara D’Avanzo,
Mauro Tettamanti,
Igor Monti,
Andrea Aguglia,
Eugenio Aguglia,
Maria Chiara Alessi,
Mario Amore,
Francesco Bartoli,
Massimo Biondi,
Paola Bortolaso,
Camilla Callegari,
Giuseppe Carrà,
Rosangela Caruso,
Simone Cavallotti,
Cristina Crocamo,
Armando D’Agostino,
Pasquale De Fazio,
Chiara Di Natale,
Laura Giusti,
Luigi Grassi,
Giovanni Martinotti,
Michela Nosé,
Davide Papola,
Marianna Purgato,
Alessandro Rodolico,
Rita Roncone,
Lorenzo Tarsitani,
Giulia Turrini,
Elisa Zanini,
Francesco Amaddeo,
Mirella Ruggeri,
Corrado Barbui
Affiliations
Giovanni Ostuzzi
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Chiara Gastaldon
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Angelo Barbato
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Barbara D’Avanzo
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Mauro Tettamanti
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Igor Monti
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Andrea Aguglia
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics Maternal and Child Health, University of Genoa
Eugenio Aguglia
Department of Clinical and Experimental Medicine, Psychiatry Unit, University of Catania, U.O.C. Clinica Psichiatrica, A.O.U. Policlinico-Vittorio Emanuele, Presidio “G. Rodolico”
Maria Chiara Alessi
Dipartimento di Neuroscienze, Imaging e Scienze Cliniche Università “G. D’Annunzio Chieti-Pescara”
Mario Amore
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics Maternal and Child Health, University of Genoa
Francesco Bartoli
Dipartimento di Medicina e Chirurgia, Università di Milano Bicocca
Massimo Biondi
Department of Human Neurosciences, Sapienza University of Rome
Paola Bortolaso
Department of Medicine and Surgery, Division of Psychiatry, University of Insubria
Camilla Callegari
Department of Medicine and Surgery, Division of Psychiatry, University of Insubria
Giuseppe Carrà
Dipartimento di Medicina e Chirurgia, Università di Milano Bicocca
Rosangela Caruso
Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara
Simone Cavallotti
Department of Mental Health, ASST Santi Paolo e Carlo
Cristina Crocamo
Dipartimento di Medicina e Chirurgia, Università di Milano Bicocca
Armando D’Agostino
Department of Mental Health, ASST Santi Paolo e Carlo
Pasquale De Fazio
Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia
Chiara Di Natale
Dipartimento di Neuroscienze, Imaging e Scienze Cliniche Università “G. D’Annunzio Chieti-Pescara”
Laura Giusti
Dipartimento di Medicina Clinica, Sanità Pubblica, Scienze della Vita e dell’Ambiente, Università degli Studi dell’Aquila
Luigi Grassi
Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara
Giovanni Martinotti
Dipartimento di Neuroscienze, Imaging e Scienze Cliniche Università “G. D’Annunzio Chieti-Pescara”
Michela Nosé
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Davide Papola
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Marianna Purgato
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Alessandro Rodolico
Department of Clinical and Experimental Medicine, Psychiatry Unit, University of Catania, U.O.C. Clinica Psichiatrica, A.O.U. Policlinico-Vittorio Emanuele, Presidio “G. Rodolico”
Rita Roncone
Dipartimento di Medicina Clinica, Sanità Pubblica, Scienze della Vita e dell’Ambiente, Università degli Studi dell’Aquila
Lorenzo Tarsitani
Department of Human Neurosciences, Sapienza University of Rome
Giulia Turrini
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Elisa Zanini
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Francesco Amaddeo
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Mirella Ruggeri
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Corrado Barbui
Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona
Abstract 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.
