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1. Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Author

Aguglia, Eugenio, Aguglia, Andrea, Alessi, Maria Chiara, Avincola, Gabriele, Bachi, Bianca, Barbato, Angelo, Barbui, Corrado, Bartoli, Francesco, Bernasconi, Gianna, Birgillito, Andrea, Bisso, Emanuele, Bonora, Stefano, Calabrese, Angela, Callegari, Camilla, Callovini, Tommaso, Canestro, Aurelia, Canonico, Salvo, Capogrosso, Chiara Alessandro, Carbone, Elvira, Carosielli, Doriana, Carrà, Giuseppe, Cartabia, Massimo, Caselli, Ivano, Cavaleri, Daniele, Cavallotti, Simone, Cavallotto, Clara, Cesca, Marco, Chiarenza, Cecilia, Cioni, Riccardo Matteo, Coloccini, Sara, Cruciata, Marco, Cumerlato, Claudia, D'Agostino, Armando, D'Avanzo, Barbara, De Fazio, Pasquale, De Filippis, Renato, De Palma, Manuela, Del Vecchio, Sasha, Della Rocca, Bianca, Di Natale, Chiara, D'Onofrio, Ettore, Espa, Irene, Fior, Giulia, Gancitano, Marta, Gari, Matteo, Gastaldon, Chiara, Giordano, Barbara, Giusti, Laura, Grassi, Luigi, Guzzi, Pierluca, Ielmini, Marta, Ingrosso, Gianmarco, Isella, Celeste, Lax, Annamaria, Mammarella, Silvia, Marano, Leonardo, Marconi, Federico, Marella, Marco, Metelli, Alessia, Michencig, Giulia, Miuli, Andrea, Moncada, Alessandro, Monti, Igor, Morello, Pietro, Moretti, Federico, Morreale, Marco, Mosca, Alessio, Nasti, Christian, Nosé, Michela, Ogheri, Filippo, Oresti, Margherita, Ornaghi, Alessandra, Ostuzzi, Giovanni, Palpella, Dario, Pancheri, Corinna, Papola, Davide, Passeri, Silvia, Pettorusso, Mauro, Piacenti, Susanna, Pinucci, Irene, Pugliese, Valentina, Purgato, Marianna, Rania, Marianna, Robbi, Federica, Rodolico, Alessandro, Romito, Samantha, Ronchi, Barbara, Roncone, Rita, Roselli, Valentina, Segura-Garcia, Cristina, Signorelli, Maria Salvina, Simonelli, Gabriele, Sociali, Antonella, Sterzi, Enrico, Sturiale, Serena, Tambelli, Antonio, Tettamanti, Mauro, Todesco, Beatrice, Trabucco, Alice, Turrini, Giulia, Villa, Veronica, Wiedenmann, Federico, Zambuto, Luca, Zanini, Elisa, Zannini, Chiara, Zerbinati, Luigi, Canozzi, Andrea, Carbone, Elvira Anna, Caruso, Rosangela, Chiappini, Stefania, Colasante, Fabrizio, Compri, Beatrice, de Filippis, Renato, Martinotti, Giovanni, Tarsitani, Lorenzo, Tiberto, Elisa, Todini, Liliana, and Amaddeo, Francesco

Published
2024
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2. Fall-related injuries in a nursing home setting: is polypharmacy a risk factor?

Author

Colli Cristiano, Costantini Chiara, Cazzamalli Sara, Poloni Nicola, Ceccon Francesca, Diurni Marcello, Baranzini Federico, Greco Laura, and Callegari Camilla

Subjects
Public aspects of medicine, RA1-1270
Abstract

Abstract Background Polypharmacy is regarded as an important risk factor for fallingand several studies and meta-analyses have shown an increased fall risk in users of diuretics, type 1a antiarrhythmics, digoxin and psychotropic agents. In particular, recent evidence has shown that fall risk is associated with the use of polypharmacy regimens that include at least one established fall risk-increasing drug, rather than with polypharmacy per se. We studied the role of polypharmacy and the role of well-known fall risk-increasing drugs on the incidence of injurious falls. Methods A retrospective observational study was carried out in a population of elderly nursing home residents. An unmatched, post-stratification design for age class, gender and length of stay was adopted. In all, 695 falls were recorded in 293 residents. Results 221 residents (75.4%) were female and 72 (24.6%) male, and 133 (45.4%) were recurrent fallers. 152 residents sustained no injuries when they fell, whereas injuries were sustained by 141: minor in 95 (67.4%) and major in 46 (32.6%). Only fall dynamics (p = 0.013) and drugs interaction between antiarrhythmic or antiparkinson class and polypharmacy regimen (≥7 medications) seem to represent a risk association for injuries (p = 0.024; OR = 4.4; CI 95% 1.21 - 15.36). Conclusion This work reinforces the importance of routine medication reviews, especially in residents exposed to polypharmacy regimens that include antiarrhythmics or antiparkinson drugs, in order to reduce the risk of fall-related injuries during nursing home stays.

Published
2009
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3. Two years of psychogeriatric consultations in a nursing home: reasons for referral compared to psychiatrists' assessment

Author

Costantini Chiara, Beraldo Scilla, Croci Giovanni, Menchetti Marco, Callegari Camilla MT, and Baranzini Federico

Subjects
Public aspects of medicine, RA1-1270
Abstract

Abstract Background In spite of the high prevalence of psychiatric disorders among elderly residents in nursing homes, only a small number of patients in need of specialist care are referred to a psychiatric consultant. The aim of this research was to evaluate the consultation activity and the appropriateness of referral to psychiatric assessment. Methods Data were collected and analysed on consultation carried out over a two-year period in a RSA (Residenza Socio-Assistenziale) in Northern-Italy. Data were catalogued with reference to: patients, consultation, diagnosis and recommended medications. Statistical correlation analysis by means of Spearman test and signification test was carried out. Results Residents referred to psychiatric consultation at least once were 112 (14.5% of all residents). Reason for referral were: depression (17.2%), delusions and hallucinations (14%), agitation (34.8%), aggressive behaviour (23.5%) and disturbances of sleep (6.8%). Most frequent diagnoses were organic, including symptomatic, mental disorders (33.9%), mood disorders (22.3%) and schizophrenia, schizotypal and delusional syndromes (18.8%). No psychiatric diagnosis was found only in 1.8% of cases, thus confirming high sensibility of referring physicians. A statistically significant correlation was found when comparing referrals for depression or delusions and allucinations or sleep disturbances and diagnostic confirmation of such symptoms by specialistic assessment (respectively 49.8%, 52.7% and 19.6%). Correlation between psychotic symptoms and the consequent prescription of antipsychotic drugs had a significant if somewhat modest value (24%) while correlation between depression symptoms and prescription of antidepressant drugs was more noticeable (66.5%). Conclusion Main reason for referral to psychiatric consultation resulted to be the presence of agitation, a non-specific symptom often difficult to attribute. Data concerning depression confirm tendency to underestimating this diagnosis in the elderly. Furthermore, symptomatic reasons for referral did not always correspond to subsequent diagnostic definitions by psychiatric consultants, therefore demonstrating modest predictive power.

Published
2006
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8. Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Author

Ostuzzi, Giovanni, primary, Gastaldon, Chiara, additional, Tettamanti, Mauro, additional, Cartabia, Massimo, additional, Monti, Igor, additional, Aguglia, Andrea, additional, Aguglia, Eugenio, additional, Bartoli, Francesco, additional, Callegari, Camilla, additional, Canozzi, Andrea, additional, Carbone, Elvira Anna, additional, Carrà, Giuseppe, additional, Caruso, Rosangela, additional, Cavallotti, Simone, additional, Chiappini, Stefania, additional, Colasante, Fabrizio, additional, Compri, Beatrice, additional, D'Agostino, Armando, additional, De Fazio, Pasquale, additional, de Filippis, Renato, additional, Gari, Matteo, additional, Ielmini, Marta, additional, Ingrosso, Gianmarco, additional, Mammarella, Silvia, additional, Martinotti, Giovanni, additional, Rodolico, Alessandro, additional, Roncone, Rita, additional, Sterzi, Enrico, additional, Tarsitani, Lorenzo, additional, Tiberto, Elisa, additional, Todini, Liliana, additional, Amaddeo, Francesco, additional, D'Avanzo, Barbara, additional, Barbato, Angelo, additional, Barbui, Corrado, additional, Alessi, Maria Chiara, additional, Avincola, Gabriele, additional, Bachi, Bianca, additional, Bernasconi, Gianna, additional, Birgillito, Andrea, additional, Bisso, Emanuele, additional, Bonora, Stefano, additional, Calabrese, Angela, additional, Callovini, Tommaso, additional, Canestro, Aurelia, additional, Canonico, Salvo, additional, Capogrosso, Chiara Alessandro, additional, Carbone, Elvira, additional, Carosielli, Doriana, additional, Caselli, Ivano, additional, Cavaleri, Daniele, additional, Cavallotto, Clara, additional, Cesca, Marco, additional, Chiarenza, Cecilia, additional, Cioni, Riccardo Matteo, additional, Coloccini, Sara, additional, Cruciata, Marco, additional, Cumerlato, Claudia, additional, De Filippis, Renato, additional, De Palma, Manuela, additional, Del Vecchio, Sasha, additional, Della Rocca, Bianca, additional, Di Natale, Chiara, additional, D'Onofrio, Ettore, additional, Espa, Irene, additional, Fior, Giulia, additional, Gancitano, Marta, additional, Giordano, Barbara, additional, Giusti, Laura, additional, Grassi, Luigi, additional, Guzzi, Pierluca, additional, Isella, Celeste, additional, Lax, Annamaria, additional, Marano, Leonardo, additional, Marconi, Federico, additional, Marella, Marco, additional, Metelli, Alessia, additional, Michencig, Giulia, additional, Miuli, Andrea, additional, Moncada, Alessandro, additional, Morello, Pietro, additional, Moretti, Federico, additional, Morreale, Marco, additional, Mosca, Alessio, additional, Nasti, Christian, additional, Nosé, Michela, additional, Ogheri, Filippo, additional, Oresti, Margherita, additional, Ornaghi, Alessandra, additional, Ostuzzi, Giovanni, additional, Palpella, Dario, additional, Pancheri, Corinna, additional, Papola, Davide, additional, Passeri, Silvia, additional, Pettorusso, Mauro, additional, Piacenti, Susanna, additional, Pinucci, Irene, additional, Pugliese, Valentina, additional, Purgato, Marianna, additional, Rania, Marianna, additional, Robbi, Federica, additional, Romito, Samantha, additional, Ronchi, Barbara, additional, Roselli, Valentina, additional, Segura-Garcia, Cristina, additional, Signorelli, Maria Salvina, additional, Simonelli, Gabriele, additional, Sociali, Antonella, additional, Sturiale, Serena, additional, Tambelli, Antonio, additional, Todesco, Beatrice, additional, Trabucco, Alice, additional, Turrini, Giulia, additional, Villa, Veronica, additional, Wiedenmann, Federico, additional, Zambuto, Luca, additional, Zanini, Elisa, additional, Zannini, Chiara, additional, and Zerbinati, Luigi, additional

Published
2024
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9. Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Author

Ostuzzi, G, Gastaldon, C, Tettamanti, M, Cartabia, M, Monti, I, Aguglia, A, Aguglia, E, Bartoli, F, Callegari, C, Canozzi, A, Carbone, E, Carrà, G, Caruso, R, Cavallotti, S, Chiappini, S, Colasante, F, Compri, B, D'Agostino, A, De Fazio, P, de Filippis, R, Gari, M, Ielmini, M, Ingrosso, G, Mammarella, S, Martinotti, G, Rodolico, A, Roncone, R, Sterzi, E, Tarsitani, L, Tiberto, E, Todini, L, Amaddeo, F, D'Avanzo, B, Barbato, A, Barbui, C, Alessi, M, Avincola, G, Bachi, B, Bernasconi, G, Birgillito, A, Bisso, E, Bonora, S, Calabrese, A, Callovini, T, Canestro, A, Canonico, S, Capogrosso, C, Carosielli, D, Caselli, I, Cavaleri, D, Cavallotto, C, Cesca, M, Chiarenza, C, Cioni, R, Coloccini, S, Cruciata, M, Cumerlato, C, De Filippis, R, De Palma, M, Del Vecchio, S, Della Rocca, B, Di Natale, C, D'Onofrio, E, Espa, I, Fior, G, Gancitano, M, Giordano, B, Giusti, L, Grassi, L, Guzzi, P, Isella, C, Lax, A, Marano, L, Marconi, F, Marella, M, Metelli, A, Michencig, G, Miuli, A, Moncada, A, Morello, P, Moretti, F, Morreale, M, Mosca, A, Nasti, C, Nosé, M, Ogheri, F, Oresti, M, Ornaghi, A, Palpella, D, Pancheri, C, Papola, D, Passeri, S, Pettorusso, M, Piacenti, S, Pinucci, I, Pugliese, V, Purgato, M, Rania, M, Robbi, F, Romito, S, Ronchi, B, Roselli, V, Segura-Garcia, C, Signorelli, M, Simonelli, G, Sociali, A, Sturiale, S, Tambelli, A, Todesco, B, Trabucco, A, Turrini, G, Villa, V, Wiedenmann, F, Zambuto, L, Zanini, E, Zannini, C, Zerbinati, L, Ostuzzi, Giovanni, Gastaldon, Chiara, Tettamanti, Mauro, Cartabia, Massimo, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Bartoli, Francesco, Callegari, Camilla, Canozzi, Andrea, Carbone, Elvira Anna, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Chiappini, Stefania, Colasante, Fabrizio, Compri, Beatrice, D'Agostino, Armando, De Fazio, Pasquale, de Filippis, Renato, Gari, Matteo, Ielmini, Marta, Ingrosso, Gianmarco, Mammarella, Silvia, Martinotti, Giovanni, Rodolico, Alessandro, Roncone, Rita, Sterzi, Enrico, Tarsitani, Lorenzo, Tiberto, Elisa, Todini, Liliana, Amaddeo, Francesco, D'Avanzo, Barbara, Barbato, Angelo, Barbui, Corrado, Alessi, Maria Chiara, Avincola, Gabriele, Bachi, Bianca, Bernasconi, Gianna, Birgillito, Andrea, Bisso, Emanuele, Bonora, Stefano, Calabrese, Angela, Callovini, Tommaso, Canestro, Aurelia, Canonico, Salvo, Capogrosso, Chiara Alessandra, Carbone, Elvira, Carosielli, Doriana, Caselli, Ivano, Cavaleri, Daniele, Cavallotto, Clara, Cesca, Marco, Chiarenza, Cecilia, Cioni, Riccardo Matteo, Coloccini, Sara, Cruciata, Marco, Cumerlato, Claudia, De Filippis, Renato, De Palma, Manuela, Del Vecchio, Sasha, Della Rocca, Bianca, Di Natale, Chiara, D'Onofrio, Ettore, Espa, Irene, Fior, Giulia, Gancitano, Marta, Giordano, Barbara, Giusti, Laura, Grassi, Luigi, Guzzi, Pierluca, Isella, Celeste, Lax, Annamaria, Marano, Leonardo, Marconi, Federico, Marella, Marco, Metelli, Alessia, Michencig, Giulia, Miuli, Andrea, Moncada, Alessandro, Morello, Pietro, Moretti, Federico, Morreale, Marco, Mosca, Alessio, Nasti, Christian, Nosé, Michela, Ogheri, Filippo, Oresti, Margherita, Ornaghi, Alessandra, Palpella, Dario, Pancheri, Corinna, Papola, Davide, Passeri, Silvia, Pettorusso, Mauro, Piacenti, Susanna, Pinucci, Irene, Pugliese, Valentina, Purgato, Marianna, Rania, Marianna, Robbi, Federica, Romito, Samantha, Ronchi, Barbara, Roselli, Valentina, Segura-Garcia, Cristina, Signorelli, Maria Salvina, Simonelli, Gabriele, Sociali, Antonella, Sturiale, Serena, Tambelli, Antonio, Todesco, Beatrice, Trabucco, Alice, Turrini, Giulia, Villa, Veronica, Wiedenmann, Federico, Zambuto, Luca, Zanini, Elisa, Zannini, Chiara, Zerbinati, Luigi, Ostuzzi, G, Gastaldon, C, Tettamanti, M, Cartabia, M, Monti, I, Aguglia, A, Aguglia, E, Bartoli, F, Callegari, C, Canozzi, A, Carbone, E, Carrà, G, Caruso, R, Cavallotti, S, Chiappini, S, Colasante, F, Compri, B, D'Agostino, A, De Fazio, P, de Filippis, R, Gari, M, Ielmini, M, Ingrosso, G, Mammarella, S, Martinotti, G, Rodolico, A, Roncone, R, Sterzi, E, Tarsitani, L, Tiberto, E, Todini, L, Amaddeo, F, D'Avanzo, B, Barbato, A, Barbui, C, Alessi, M, Avincola, G, Bachi, B, Bernasconi, G, Birgillito, A, Bisso, E, Bonora, S, Calabrese, A, Callovini, T, Canestro, A, Canonico, S, Capogrosso, C, Carosielli, D, Caselli, I, Cavaleri, D, Cavallotto, C, Cesca, M, Chiarenza, C, Cioni, R, Coloccini, S, Cruciata, M, Cumerlato, C, De Filippis, R, De Palma, M, Del Vecchio, S, Della Rocca, B, Di Natale, C, D'Onofrio, E, Espa, I, Fior, G, Gancitano, M, Giordano, B, Giusti, L, Grassi, L, Guzzi, P, Isella, C, Lax, A, Marano, L, Marconi, F, Marella, M, Metelli, A, Michencig, G, Miuli, A, Moncada, A, Morello, P, Moretti, F, Morreale, M, Mosca, A, Nasti, C, Nosé, M, Ogheri, F, Oresti, M, Ornaghi, A, Palpella, D, Pancheri, C, Papola, D, Passeri, S, Pettorusso, M, Piacenti, S, Pinucci, I, Pugliese, V, Purgato, M, Rania, M, Robbi, F, Romito, S, Ronchi, B, Roselli, V, Segura-Garcia, C, Signorelli, M, Simonelli, G, Sociali, A, Sturiale, S, Tambelli, A, Todesco, B, Trabucco, A, Turrini, G, Villa, V, Wiedenmann, F, Zambuto, L, Zanini, E, Zannini, C, Zerbinati, L, Ostuzzi, Giovanni, Gastaldon, Chiara, Tettamanti, Mauro, Cartabia, Massimo, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Bartoli, Francesco, Callegari, Camilla, Canozzi, Andrea, Carbone, Elvira Anna, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Chiappini, Stefania, Colasante, Fabrizio, Compri, Beatrice, D'Agostino, Armando, De Fazio, Pasquale, de Filippis, Renato, Gari, Matteo, Ielmini, Marta, Ingrosso, Gianmarco, Mammarella, Silvia, Martinotti, Giovanni, Rodolico, Alessandro, Roncone, Rita, Sterzi, Enrico, Tarsitani, Lorenzo, Tiberto, Elisa, Todini, Liliana, Amaddeo, Francesco, D'Avanzo, Barbara, Barbato, Angelo, Barbui, Corrado, Alessi, Maria Chiara, Avincola, Gabriele, Bachi, Bianca, Bernasconi, Gianna, Birgillito, Andrea, Bisso, Emanuele, Bonora, Stefano, Calabrese, Angela, Callovini, Tommaso, Canestro, Aurelia, Canonico, Salvo, Capogrosso, Chiara Alessandra, Carbone, Elvira, Carosielli, Doriana, Caselli, Ivano, Cavaleri, Daniele, Cavallotto, Clara, Cesca, Marco, Chiarenza, Cecilia, Cioni, Riccardo Matteo, Coloccini, Sara, Cruciata, Marco, Cumerlato, Claudia, De Filippis, Renato, De Palma, Manuela, Del Vecchio, Sasha, Della Rocca, Bianca, Di Natale, Chiara, D'Onofrio, Ettore, Espa, Irene, Fior, Giulia, Gancitano, Marta, Giordano, Barbara, Giusti, Laura, Grassi, Luigi, Guzzi, Pierluca, Isella, Celeste, Lax, Annamaria, Marano, Leonardo, Marconi, Federico, Marella, Marco, Metelli, Alessia, Michencig, Giulia, Miuli, Andrea, Moncada, Alessandro, Morello, Pietro, Moretti, Federico, Morreale, Marco, Mosca, Alessio, Nasti, Christian, Nosé, Michela, Ogheri, Filippo, Oresti, Margherita, Ornaghi, Alessandra, Palpella, Dario, Pancheri, Corinna, Papola, Davide, Passeri, Silvia, Pettorusso, Mauro, Piacenti, Susanna, Pinucci, Irene, Pugliese, Valentina, Purgato, Marianna, Rania, Marianna, Robbi, Federica, Romito, Samantha, Ronchi, Barbara, Roselli, Valentina, Segura-Garcia, Cristina, Signorelli, Maria Salvina, Simonelli, Gabriele, Sociali, Antonella, Sturiale, Serena, Tambelli, Antonio, Todesco, Beatrice, Trabucco, Alice, Turrini, Giulia, Villa, Veronica, Wiedenmann, Federico, Zambuto, Luca, Zanini, Elisa, Zannini, Chiara, and Zerbinati, Luigi

Abstract

Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depress

Published
2024

11. 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

Author

Ostuzzi, Giovanni, Gastaldon, Chiara, Barbato, Angelo, D’Avanzo, Barbara, Tettamanti, Mauro, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Alessi, Maria Chiara, Amore, Mario, Bartoli, Francesco, Biondi, Massimo, Bortolaso, Paola, Callegari, Camilla, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Crocamo, Cristina, D’Agostino, Armando, De Fazio, Pasquale, Di Natale, Chiara, Giusti, Laura, Grassi, Luigi, Martinotti, Giovanni, Nosé, Michela, Papola, Davide, Purgato, Marianna, Rodolico, Alessandro, Roncone, Rita, Tarsitani, Lorenzo, Turrini, Giulia, Zanini, Elisa, Amaddeo, Francesco, Ruggeri, Mirella, and Barbui, Corrado

Published
2020
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15. THE IMPACT OF COVID-19 PANDEMIC ON MENTAL HEALTH SERVICES: A COMPARISON BETWEEN FIRST PSYCHIATRIC CONSULTATIONS BEFORE AND AFTER THE PANDEMIC.

Author

Caselli, Ivano, Ielmini, Marta, Bellini, Alessandro, Marchetti, Silvio, Lucca, Giulia, Vitiello, Erica, Carbone, Manuel Glauco, and Callegari, Camilla

Subjects
MENTAL health services, COVID-19 pandemic, PANDEMICS, HOSPITAL emergency services, CONSULTATION-liaison psychiatry, PSYCHIATRIC diagnosis, PSYCHIATRIC nursing
Abstract

Objective: A high rate of onset or exacerbation of several mental disorders has been observed during the COVID-19 pandemic. However, the risk contributing to mental distress during the pandemic remains unclear. The study aims to evaluate the risk of the onset of mental disorders by comparing the number of requests for the first psychiatric consultation before and after the COVID-19 pandemic at the psychiatric outpatient services of Varese, a small town in Northern Italy. Method: This observational retrospective study aims to compare the requests for the first psychiatric consultation at the outpatient services of Varese during the 14-month period before COVID-19 pandemic (from 1st January 2019 to 28th February 2020) versus the 14-month period after the pandemic (from 1st March 2020 to 31st May 2021) extracted from the server SIPRL-Psicheweb database (Sistema Informativo della Psichiatria, Lombardy Region). For each patient, socio-demographic features and clinical data (psychiatric diagnosis, psychiatric comorbidities, previous psychiatric records, and previous hospitalization in the psychiatric ward) were collected. Results: Three hundred ninety-five consultations were made during the pre- COVID period and 346 during the post-COVID period. No statistically significant difference was found between the number of first consultation requests in the two periods evaluated but a slight decrease in the total number during the pandemic period (395 vs 346; p=0.07) can be noticed. In the subjects of the pre-COVID group, a statistically significant association was detected with no previous psychiatric records ("absent") and with stressor-related disorders. In the post- COVID group, a statistically significant correlation between "present" previous records and anxiety-depressive disorders emerged. Conclusions: It has been observed that anxiety-depressive disorders increased in the post-COVID-19 period compared to the pre-COVID-19, instead of stressorrelated disorders. This might be because stressor-related disorders may be treated by general practitioners with no psychiatric interventions. Most of the first consultations during the period of the COVID-19 pandemic were for patients who already had contact with psychiatric services. The study shows an increasing request for care by more severe patients in the first phase of the SARS-CoV-2 pandemic. Further research is needed to investigate the long-term impact of the COVID-19 pandemic on emergency departments and hospital services. [ABSTRACT FROM AUTHOR]

Published
2023
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19. Off-label long acting injectable antipsychotics in real-world clinical practice: a cross-sectional analysis of prescriptive patterns from the STAR Network DEPOT study

Author

D'Agostino, Armando, Aguglia, Andrea, Barbui, Corrado, Bartoli, Francesco, Carrà, Giuseppe, Cavallotti, Simone, Chirico, Margherita, Ostinelli, Edoardo G, Zangani, Caroline, Martinotti, Giovanni, Ostuzzi, Giovanni, Bertolini, Federico, Calandra, Carmela, Callegari, Camilla, D’Agostino, Armando, Lucii, Claudio, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Nose, Michela, Purgato, Marianna, Turrini, Giulia, Mazzi, Maria, Angela, Papola, Davide, Gastaldon, Chiara, Terlizzi, Samira, Piccoli, Alberto, Ruggeri, Mirella, De Fazio, Pasquale, Magliocco, Fabio, Caroleo, Mariarita, Raffaele, Gaetano, Ostinelli, Edoardo, Giuseppe, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua, Maria, Cerretini, Massimiliano, Tozzi, Fiorella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Zizolfi, Daniele, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Emanuele, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Bortolaso, Paola, Piccinelli, Marco, Cazzamalli, Sara, Caterina, Alberini, Gabro, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti Silva, Veronica, Papalini, Alessandro, Corbo, Mariangela, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria, Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Carra, Giuseppe, Tabacchi, Tommaso, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora, Tremolada, Martina, Castagna, Gloria, Bava, Mattia, Verrengia, Enrica, Lucchi, Sara, Oriani, Maria, Ginevra, Barchiesi, Michela, Pacetti, Monica, Magni, Laura, Rosa, Rossi, Giuseppe, Beneduce, Rossella, Tura, Giovanni, Battista, Laffranchini, Laura, Ferrato, Farida, Restaino, Francesco, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo, Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Di Benedetto, Rossella, Pinna, Federica, Carpiniello, Bernardo, Spano, Mariangela, Giacomin, Marzio, Pecile, Damiano, Mattei, Chiara, Fabrici, Elisabetta, Pascolo, Panarello, Sofia, Peresson, Giulia, Vitucci, Claudio, Bonavigo, Tommaso, Perini, Giovanni, Boschello, Filippo, Strizzolo, Stefania, Gardellin, Francesco, Di Giannantonio, Massimo, Fizzotti, Carlo, Cossetta, Edoardo, Di Gregorio, Luana, Sozzi, Francesca, Boncompagni, Giancarlo, La Barbera, Daniele, Colli, Giuseppe, Laurenzi, Sabrina, Luca, Maria, D'Agostino A., Aguglia A., Barbui C., Bartoli F., Carra G., Cavallotti S., Chirico M., Ostinelli E.G., Zangani C., Martinotti G., Ostuzzi G., Nose M., Purgato M., Turrini G., Mazzi M.A., Papola D., Gastaldon C., Terlizzi S., Bertolini F., Piccoli A., Ruggeri M., De Fazio P., Magliocco F., Caroleo M., Raffaele G., Bergamelli E., Lucii C., Bolognesi S., Debolini S., Pierantozzi E., Fargnoli F., Del Zanna M., Giannini A., Luccarelli L., De Capua A., Annese P.M., Cerretini M., Tozzi F., Magnani N., Cardamone G., Bardicchia F., Facchi E., Soscia F., Zotos S., Biancosino B., Zonta F., Pompei F., Callegari C., Zizolfi D., Poloni N., Ielmini M., Caselli I., Giana E., Buzzi A., Diurni M., Milano A., Sani E., Calzolari R., Bortolaso P., Piccinelli M., Cazzamalli S., Alberini G., Piantanida S., Costantini C., Paronelli C., Di Caro A., Moretti V., Gozzi M., D'Ippolito C., Barbanti S.V., Alessandro P., Corbo M., Campese O., Fiori F., Lorusso M., Di Capro L., Viceconte D., Mancini V., Suraniti F., Signorelli M.S., Rossi E., Lupoli P., Menchetti M., Terzi L., Boso M., Risaro P., De Paoli G., Catania C., Tarricone I., Caretto V., Storbini V., Emiliani R., Balzarro B., Tabacchi T., Nava R., Bono A., Provenzi M., Brambilla G., Aspesi F., Trotta G., Tremolada M., Castagna G., Bava M., Verrengia E., Lucchi S., Oriani M.G., Barchiesi M., Pacetti M., Amerio A., Amore M., Serafini G., Magni L.R., Rossi G., Beneduce R., Tura G.B., Laffranchini L., Mastromo D., Ferrato F., Restaino F., Monzani E., Porcellana M., Limosani I., Ghio L., Ferro M., Parise V.F., Balletta G., Addeo L., De Vivo E., Di Benedetto R., Pinna F., Carpiniello B., Spano M., Giacomin M., Pecile D., Mattei C., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Bonavigo T., Perini G., Boschello F., Strizzolo S., Gardellin F., di Giannantonio M., Moretti D., Fizzotti C., Cossetta E., Di Gregorio L., Sozzi F., Boncompagni G., La Barbera D., Colli G., Laurenzi S., Calandra C., Luca M., D'Agostino, A, Aguglia, A, Barbui, C, Bartoli, F, Carra, G, Cavallotti, S, Chirico, M, Ostinelli, E, Zangani, C, Martinotti, G, Ostuzzi, G, D'Agostino, Armando, Aguglia, Andrea, Barbui, Corrado, Bartoli, Francesco, Carrà, Giuseppe, Cavallotti, Simone, Chirico, Margherita, Ostinelli, Edoardo G, Zangani, Caroline, Martinotti, Giovanni, Ostuzzi, Giovanni, and LA BARBERA, DANIELE

Subjects
Long-acting injectable antipsychotic, Cross-Sectional Studies, Off-label, Personality disorder, Bipolar disorder, Delayed-Action Preparations, Schizophrenia, Humans, Long-acting injectable antipsychotics, Off-Label Use, Antipsychotic Agents, Settore MED/25 - Psichiatria
Abstract

Introduction: Information on the off–label use of Long–Acting Injectable (LAI) antipsychotics in the real world is lacking. In this study, we aimed to identify the sociodemographic and clinical features of patients treated with on– vs off–label LAIs and predictors of off–label First– or Second–Generation Antipsychotic (FGA vs. SGA) LAI choice in everyday clinical practice. Method: In a naturalistic national cohort of 449 patients who initiated LAI treatment in the STAR Network Depot Study, two groups were identified based on off– or on–label prescriptions. A multivariate logistic regression analysis was used to test several clinically relevant variables and identify those associated with the choice of FGA vs SGA prescription in the off–label group. Results: SGA LAIs were more commonly prescribed in everyday practice, without significant differences in their on– and off–label use. Approximately 1 in 4 patients received an off–label prescription. In the off–label group, the most frequent diagnoses were bipolar disorder (67.5%) or any personality disorder (23.7%). FGA vs SGA LAI choice was significantly associated with BPRS thought disorder (OR = 1.22, CI95% 1.04 to 1.43, p= 0.015) and hostility/suspiciousness (OR = 0.83, CI95% 0.71 to 0.97, p= 0.017) dimensions. The likelihood of receiving an SGA LAI grew steadily with the increase of the BPRS thought disturbance score. Conversely, a preference towards prescribing an FGA was observed with higher scores at the BPRS hostility/suspiciousness subscale. Conclusion: Our study is the first to identify predictors of FGA vs SGA choice in patients treated with off–label LAI antipsychotics. Demographic characteristics, i.e. age, sex, and substance/alcohol use co–morbidities did not appear to influence the choice towards FGAs or SGAs. Despite a lack of evidence, clinicians tend to favour FGA over SGA LAIs in bipolar or personality disorder patients with relevant hostility. Further research is needed to evaluate treatment adherence and clinical effectiveness of these prescriptive patterns.

Published
2022

21. Improving equity in the kidney transplant continuum for non-European-born patients living in Italy: preliminary case-series findings of the contribution of pre-transplant ethical assessments.

Author

Grossi, Alessandra Agnese, Caselli, Ivano, Nicoli, Federico, Ceruti, Silvia, Testa, Jacopo, Tantardini, Cristina, Callegari, Camilla, and Picozzi, Mario

Subjects
KIDNEY transplantation, JUSTICE, DUTY
Abstract

The care of migrants pursuing kidney transplant (KT) is emergent in Europe. Studies emphasize the ethical duty to adopt a holistic approach to these patients to enable the identification of modifiable risk factors and provide tailored interventions to prevent inequities. The ethical challenge at the time of pre-transplant evaluations is to determine – and balance – the prospective benefit of KT for individual patients (beneficence/non-maleficence) and all candidates pursuing KT (justice), without disrespecting persons (autonomy). This case-series study aims to explore the contribution of ethical assessments – by means of clinical ethics consultation – to pre-transplant evaluations for the prevention of inequities in KT, and to determine the limitations of standardized tools for pre-transplant psychosocial evaluations in non-European- born populations living in Italy. A case-series of first-generation immigrant patients enrolled for KT was analyzed using the Four-Boxes Method to explore the ethical dimensions of individual cases, and the Stanford Integrated Psychosocial Assessment for Transplant for psychosocial analyses. Ethical assessments allow identification of the individual and contextual features with the potential for detrimental impacts on equity in KT. Standardized tools do not consider the conditions associated with immigrant status which may affect the score and ability to tailor interventions to the patients' individual circumstances and disadvantage immigrant populations accordingly. This case-series study newly shows that ethical assessments may be a useful supplement to guide the examination of the ethical dimensions of individual clinical cases and to complement pre-transplant multidisciplinary evaluations, enabling a co-construction of the care process between individual patients and the transplant team. This approach shows potential to improve equity in KT care and to respect the principles of autonomy, beneficence/non-maleficence, and justice. [ABSTRACT FROM AUTHOR]

Published
2023
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22. Effect of quetiapine on inflammation and immunity: a systematic review.

Author

Ferrari, Marco, Godio, Marco, Martini, Stefano, Callegari, Camilla, Cosentino, Marco, and Marino, Franca

Subjects
DRUG therapy for schizophrenia, MENTAL illness drug therapy, ONLINE information services, BIOMARKERS, CYTOKINES, INTERLEUKINS, MEDICAL information storage & retrieval systems, HIPPOCAMPUS (Brain), NEUROBIOLOGY, QUETIAPINE, ANTI-inflammatory agents, SYSTEMATIC reviews, CATECHOLAMINES, SEROTONIN, CELLULAR signal transduction, IMMUNITY, TUMOR necrosis factors, MEDLINE, CEREBRAL cortex, BIPOLAR disorder, PHARMACODYNAMICS
Abstract

Knowledge about the neurobiology of psychiatric disorders is increasing in the last decades and evidence from literature suggests a central role for immuno-inflammatory mechanisms in these illnesses. The antipsychotic quetiapine acts on dopamine and serotonin signalling and well-established evidence demonstrates that these neurotransmitters can modulate immune functions in healthy and diseased conditions. Starting from this perspective, in the last few decades, a number of studies attempted to identify quetiapine effects on immune functions in order to highlight a possible additional effect of this drug in psychotic diseases, although no conclusive results were obtained. We critically reviewed preclinical and clinical studies evaluating quetiapine effects on immune systems, suggesting strategies for future work in this field. Computerised search, in PubMed and Embase databases, was performed in March 2020: 120 studies were identified but only 29 relevant papers were selected for detailed review. Despite some interesting preliminary findings about anti-inflammatory effects of quetiapine, mainly supported by preclinical studies, it is possible to conclude further studies are needed to investigate the immunomodulatory effects of this drug and achieve a better understanding of its relevance on clinical outcomes to finally identify new therapeutic approaches in psychiatric treatment. Mounting evidence points to a role for immuno-inflammatory mechanisms in psychiatric disorders. Quetiapine (QUE) acts on catecholamine (dopamine and norepinephrine) and serotonin signalling. The immunomodulatory effects of catecholamines are well established. Treatment with QUE in psychiatric disorders could leverage immunomodulatory effects. QUE unclear role in immune function modulation suggests future work. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Comparing 1-year effectiveness and acceptability of once-monthly paliperidone palmitate and aripiprazole monohydrate for schizophrenia spectrum disorders: Findings from the STAR Network Depot Study

Author

Francesco Bartoli, A, Daniele Cavaleri, A, Tommaso Callovini, A, Ilaria Riboldi, A, Cristina Crocamo, A, Armando D’Agostino, B, Giovanni Martinotti, C, Federico Bertolini, D, Giovanni Ostuzzi, D, Corrado Barbui, D, Giuseppe Carr`a, A, STAR Network Depot Investigators, Corrado, Barbui, Federico, Bertolini, Filippo, Boschello, Chiara, Gastaldon, Maria Angela Mazzi, Michela, Nos´e, Giovanni, Ostuzzi, Davide, Papola, Giovanni, Perini, Alberto, Piccoli, Michela, Pievani, Marianna, Purgato, Mirella, Ruggeri, Federico, Tedeschi, Samira, Terlizzi, and Giulia Turrini (Verona), Mariarita, Caroleo, Pasquale De Fazio, Fabio, Magliocco, and Gaetano Raffaele (Catanzaro), Simone, Cavallotti, Margherita, Chirico, Armando, D’Agostino, Farida, Ferrato, Ivan, Limosani, Daniele, Mastromo, Emiliano, Monzani, Edoardo Giuseppe Ostinelli, Matteo, Porcellana, and Francesco Restaino (Milano), Pasqua Maria Annese, Simone, Bolognesi, Massimiliano, Cerretini, Alberto De Capua, Sara, Debolini, Maria Del Zanna, Francesco, Fargnoli, Alessandra, Giannini, Livia, Luccarelli, Claudio, Lucii, Elisa, Pierantozzi, and Fiorella Tozzi (Siena), Francesco, Bardicchia, Giuseppe, Cardamone, Edvige, Facchi, Nadia, Magnani, and Federica Soscia (Grosseto), Bruno Biancosino, and Spyridon Zotos (Ferrara), Marzio, Giacomin, Francesco, Pompei, Mariangela, Spano, and Filippo Zonta (Treviso), Buzzi, ALDO EMANUELE, Callegari, Camilla, Roberta, Calzolari, Caselli, Ivano, Marcello, Diurni, Edoardo Luigi Giana, Ielmini, Marta, Anna, Milano, Emanuele, Sani, and Daniele Zizolfi (Varese), Gabrio, Alberini, Paola, Bortolaso, Sara, Cazzamalli, Chiara, Costantini, Angela Di Caro, Chiara, Paronelli, Silvia, Piantanida, and Marco Piccinelli (Varese Verbano), Papalini, Alessandro, Silva Veronica Barbanti, Chiara, D’Ippolito, Mauro, Gozzi, and Valentina Moretti (Reggio Emilia), Ornella, Campese, Mariangela, Corbo, Lucia Di Capro, Massimo di Giannantonio, Federica, Fiori, Marco, Lorusso, Valerio, Mancini, Giovanni, Martinotti, and Daniela Viceconte (Chieti), Carmela, Calandra, Maria, Luca, Maria Salvina Signorelli, and Francesco Suraniti (Catania), Beatrice, Balzarro, Giancarlo, Boncompagni, Valentina, Caretto, Roberta, Emiliani, Pasqualino, Lupoli, Marco, Menchetti, Eugenio, Rossi, Viviana, Storbini, Ilaria, Tarricone, and Laura Terzi (Bologna), Marianna, Boso, Cristina, Catania, Giuseppe De Paoli, and Paolo Risaro (Pavia), Flora, Aspesi, Francesco, Bartoli, Mattia, Bava, Adele, Bono, Giulia, Brambilla, Giuseppe, Carr`a, Gloria, Castagna, Sara, Lucchi, Roberto, Nava, Milena, Provenzi, Tommaso, Tabacchi, Martina, Tremolada, and Enrica Verrengia (Monza), Michela Barchiesi and Maria Ginevra Oriani (Ancona), Monica Pacetti (Forlì), Andrea, Aguglia, Maurizio, Ferro, and Lucio Ghio (Genova), Rossella, Beneduce, Laura, Laffranchini, Laura Rosa Magni, Giuseppe, Rossi, and Giovanni Battista Tura (Brescia), Lelio, Addeo, Giovanni, Balletta, Elisa De Vivo, Rossella Di Benedetto, and Vincenzo Fricchione Parise (Avellino), Bernardo Carpiniello and Federica Pinna (Cagliari), Damiano Pecile (Mantova), Chiara Mattei (Fermo), Tommaso, Bonavigo, Elisabetta Pascolo Fabrici, Sofia, Panarello, Giulia, Peresson, and Claudio Vitucci (Trieste), Francesco Gardellin, and Stefania Strizzolo (Vicenza), Edoardo, Cossetta, Carlo, Fizzotti, and Daniele Moretti (Savona), Luana Di Gregorio and Francesca Sozzi (Trento), Giuseppe Colli and Daniele La Barbera (Palermo), and Sabrina Laurenzi (Civitanova, Marche)., Bartoli, F, Cavaleri, D, Callovini, T, Riboldi, I, Crocamo, C, D'Agostino, A, Martinotti, G, Bertolini, F, Ostuzzi, G, Barbui, C, Carra, G, and Bartoli, F., Cavaleri, D., Callovini, T., Riboldi, I., Crocamo, C., D'Agostino, A., Martinotti, G., Bertolini, F., Ostuzzi, G., Barbui, C., Carrà, G., Boschello, F., Gastaldon, C., Mazzi, M.A., Nosé, M., Papola, D., Perini, G., Piccoli, A., Pievani, M., Purgato, M., Ruggeri, M., Tedeschi, F., Terlizzi, S., Turrini, G., Caroleo, M., De Fazio, P., Magliocco, F., Raffaele, G., Chirico, M., Ferrato, F., Limosani, I., Mastromo, D., Monzani, E., Ostinelli, E.G., Porcellana, M., Restaino, F., Annese, P.M., Bolognesi, S., Cerretini, M., De Capua, A., Debolini, S., Del Zanna, M., Fargnoli, F., Giannini, A., Luccarelli, L., Lucii, C., Pierantozzi, E., Tozzi, F., Bardicchia, F., Cardamone, G., Facchi, E., Magnani, N., Soscia, F., Biancosino, B., Zotos, S., Giacomin, M., Pompei, F., Spano, M., Zonta, F., Buzzi, A., Callegari, C., Calzolari, R., Caselli, I., Diurni, M., Giana, E.L., Ielmini, M., Milano, A., Poloni, N., Sani, E., Zizolfi, D., Alberini, G., Bortolaso, P., Cazzamalli, S., Costantini, C., Di Caro, A., Paronelli, C., Piantanida, S., Piccinelli, M., Alessandro, P., Barbanti, S.V., D'Ippolito, C., Gozzi, M., Moretti, V., Corbo, M., Di Capro, L., di Giannantonio, M., Fiori, F., Lorusso, M., Mancini, V., Viceconte, D., Calandra, C., Luca, M., Signorelli, M.S., Suraniti, F., Balzarro, B., Boncompagni, G., Caretto, V., Emiliani, R., Lupoli, P., Menchetti, M., Rossi, E., Storbini, V., Tarricone, I., Terzi, L., Boso, M., Catania, C., De Paoli, G., Risaro, P., Aspesi, F., Bava, M., Bono, A., Brambilla, G., Castagna, G., Lucchi, S., Nava, R., Provenzi, M., Tabacchi, T., Tremolada, M., Verrengia, E., Barchiesi, M., Oriani, M.G., Aguglia, A., Ferro, M., Ghio, L., Beneduce, R., Laffranchini, L., Magni, L.R., Rossi, G., Tura, G.B., Addeo, L., Balletta, G., De Vivo, E., Di Benedetto, R., Parise, V.F., Carpiniello, B., Pinna, F., Pecile, D., Mattei, C., Bonavigo, T., Fabrici, E.P., Panarello, S., Peresson, G., Vitucci, C., Pacetti, M., Gardellin, F., Strizzolo, S., Cossetta, E., Fizzotti, C., Moretti, D., Di Gregorio, L., Sozzi, F., Colli, G., La Barbera, D., Laurenzi, S.

Subjects
Long-acting injectable antipsychotic, Paliperidone palmitate 1-month, Aripiprazole, Aripiprazole monohydrate, Long-acting injectable antipsychotics, Psychiatry and Mental health, Paliperidone Palmitate, Schizophrenia, Humans, Prospective Studies, Settore MED/25 - Psichiatria, Biological Psychiatry, Antipsychotic Agents
Abstract

In this prospective study, we assessed the effectiveness and acceptability of paliperidone palmitate 1-month (PP1M) and aripiprazole monohydrate (AM) over 1-year follow-up. We included 195 subjects (117 treated with PP1M and 78 with AM) with schizophrenia spectrum disorders from real-world settings. We estimated no differences in hospitalization (Odds Ratio=1.59; p = 0.12), symptoms improvement (p = 0.90 adjusted for baseline severity), and discontinuation (Hazard Ratio=0.72; p = 0.20) at study endpoint. Although current evidence suggests the possible superiority of AM over PP1M, our findings showed comparable effectiveness between these drugs. Additional studies in real-world settings with direct comparisons between these two LAIs are needed.

Published
2022

27. The Role of Attitudes Toward Medication and Treatment Adherence in the Clinical Response to LAIs: Findings From the STAR Network Depot Study

Author

Andrea, Aguglia, Laura, Fusar-Poli, Andrea, Amerio, Valeria, Placenti, Carmen, Concerto, Giovanni, Martinotti, Giuseppe, Carrà, Francesco, Bartoli, Armando, D’Agostino, Gianluca, Serafini, Mario, Amore, Eugenio, Aguglia, Giovanni, Ostuzzi, Corrado, Barbui, e STAR Network Investigators, Michela, Nose’, Marianna, Purgato, Giulia, Turrini, Maria Angela Mazzi, Davide, Papola, Chiara, Gastaldon, Samira, Terlizzi, Federico, Bertolini, Alberto Piccoli (Verona), Mirella Ruggeri (Verona), Pasquale De Fazio (Catanzaro), Fabio Magliocco (Catanzaro), Mariarita Caroleo (Catanzaro), Gaetano Raffaele (Catanzaro), Armando D’Agostino (Milano), Edoardo Giuseppe Ostinelli (Milano), Margherita Chirico (Milano), Simone Cavallotti (Milano), Claudio Lucii (Siena), Simone Bolognesi (Siena), Sara Debolini (Siena), Elisa Pierantozzi (Siena), Francesco Fargnoli (Siena), Maria Del Zanna (Siena), Alessandra Giannini (Siena), Livia Luccarelli (Siena), Alberto De Capua (Siena), Pasqua Maria Annese (Siena), Massimiliano Cerretini (Siena), Fiorella Tozzi (Siena), Nadia Magnani (Grosseto), Giuseppe Cardamone (Grosseto), Francesco Bardicchia (Grosseto), Edvige Facchi (Grosseto), Federica Soscia (Grosseto), Spyridon Zotos (Ferrara), Bruno Biancosino (Ferrara), Filippo Zonta (Treviso), Francesco Pompei (Treviso), Callegari, Camilla, Daniele, Zizolfi, Ielmini, Marta, Caselli, Ivano, Edoardo Giana (Varese), Aldo Buzzi (Varese), Marcello Diurni (Varese), Anna Milano (Varese), Emanuele Sani (Varese), Roberta Calzolari (Varese), Paola Bortolaso (Varese Verbano), Marco Piccinelli (Varese Verbano), Sara Cazzamalli (Varese Verbano), Gabrio Alberini (Varese Verbano), Silvia Piantanida (Varese Verbano), Chiara Costantini (Varese Verbano), Chiara Paronelli (Varese Verbano), Angela Di Caro (Varese Verbano), Valentina Moretti (Reggio Emilia), Mauro Gozzi (Reggio Emilia), Chiara D’Ippolito (Reggio Emilia), Silva Veronica Barbanti (Reggio Emilia), Papalini Alessandro (Reggio Emilia), Mariangela Corbo (Chieti), Giovanni Martinotti (Chieti), Ornella Campese (Chieti), Federica Fiori (Chieti), Marco Lorusso (Chieti), Lucia Di Capro (Chieti), Daniela Viceconte (Chieti), Valerio Mancini (Chieti), Francesco Suraniti (Catania), Maria Salvina Signorelli (Catania), Eugenio Rossi (Bologna), Pasqualino Lupoli (Bologna), Marco Menchetti (Bologna), Laura Terzi (Bologna), Marianna Boso (Pavia), Paolo Risaro (Pavia), Giuseppe De Paoli (Pavia), Cristina Catania (Pavia), Ilaria Tarricone (Bologna), Valentina Caretto (Bologna), Viviana Storbini (Bologna), Roberta Emiliani (Bologna), Beatrice Balzarro (Bologna), Giuseppe Carrà (Monza), Francesco Bartoli (Monza), Tommaso Tabacchi (Monza), Roberto Nava (Monza), Adele Bono (Monza), Milena Provenzi (Monza), Giulia Brambilla (Monza), Flora Aspesi (Monza), Trotta, (Monza), Martina Tremolada (Monza), Gloria Castagna (Monza), Mattia Bava (Monza), Enrica Verrengia (Monza), Sara Lucchi (Monza), Maria Ginevra Oriani (Ancona), Michela Barchiesi (Ancona), Monica Pacetti (Forlì), Andrea Aguglia (Genova), Laura Rosa Magni (Brescia), Giuseppe Rossi (Brescia), Rossella Beneduce (Brescia), Giovanni Battista Tura (Brescia), Laura Laffranchini (Brescia), Daniele Mastromo (Milano), Farida Ferrato (Milano), Francesco Restaino (Milano), Emiliano Monzani (Milano), Matteo Porcellana (Milano), Ivan Limosani (Milano), Lucio Ghio (Genova), Maurizio Ferro (Genova), Vincenzo Fricchione Parise (Avellino), Giovanni Balletta (Avellino), Lelio Addeo (Avellino), Elisa De Vivo (Avellino), Rossella Di Benedetto (Avellino), Federica Pinna (Cagliari), Bernardo Carpiniello (Cagliari), Mariangela Spano (Treviso), Marzio Giacomin (Treviso), Damiano Pecile (Mantova), Chiara Mattei (Fermo), Elisabetta Pascolo Fabrici (Trieste), Sofia Panarello (Trieste), Giulia Peresson (Trieste), Claudio Vitucci (Trieste), Tommaso Bonavigo (Trieste), Monica Pacetti (Forli‘), Giovanni Perini (Verona), Filippo Boschello (Verona), Stefania Strizzolo (Vicenza), Francesco Gardellin (Vicenza), Massimo di Giannantonio (Chieti), Daniele Moretti (Savona), Carlo Fizzotti (Savona), Edoardo Cossetta (Savona), Luana Di Gregorio (Trento), Francesca Sozzi (Trento), Giancarlo Boncompagni (Bologna), Daniele La Barbera (Palermo), Giuseppe Colli (Palermo), Sabrina Laurenzi (Civitanova Marche), Carmela Calandra (Catania), Maria Luca, (Catania)., Aguglia, A, Fusar-Poli, L, Amerio, A, Placenti, V, Concerto, C, Martinotti, G, Carra, G, Bartoli, F, D'Agostino, A, Serafini, G, Amore, M, Aguglia, E, Ostuzzi, G, Barbui, C, Aguglia, Andrea, Fusar-Poli, Laura, Amerio, Andrea, Placenti, Valeria, Concerto, Carmen, Martinotti, Giovanni, Carrà, Giuseppe, Bartoli, Francesco, D'Agostino, Armando, Serafini, Gianluca, Amore, Mario, Aguglia, Eugenio, Ostuzzi, Giovanni, Barbui, Corrado, and LA BARBERA, DANIELE

Subjects
Psychiatry, psychotic symptom, therapeutic alliance, RC435-571, drug, antipsychotic, Psychiatry and Mental health, antipsychotics, adherence, attitude, long-acting injectable, psychotic symptoms, Original Research
Abstract

Background: Long-acting injectable (LAI) antipsychotics are efficacious in managing psychotic symptoms in people affected by severe mental disorders, such as schizophrenia and bipolar disorder. The present study aimed to investigate whether attitude toward treatment and treatment adherence represent predictors of symptoms changes over time.Methods: The STAR Network “Depot Study” was a naturalistic, multicenter, observational, prospective study that enrolled people initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centers were assessed at three time points: baseline, 6-month, and 12-month follow-up. Psychopathological symptoms, attitude toward medication and treatment adherence were measured using the Brief Psychiatric Rating Scale (BPRS), the Drug Attitude Inventory (DAI-10) and the Kemp's 7-point scale, respectively. Linear mixed-effects models were used to evaluate whether attitude toward medication and treatment adherence independently predicted symptoms changes over time. Analyses were conducted on the overall sample and then stratified according to the baseline severity (BPRS < 41 or BPRS ≥ 41).Results: We included 461 participants of which 276 were males. The majority of participants had received a primary diagnosis of a schizophrenia spectrum disorder (71.80%) and initiated a treatment with a second-generation LAI (69.63%). BPRS, DAI-10, and Kemp's scale scores improved over time. Six linear regressions—conducted considering the outcome and predictors at baseline, 6-month, and 12-month follow-up independently—showed that both DAI-10 and Kemp's scale negatively associated with BPRS scores at the three considered time points. Linear mixed-effects models conducted on the overall sample did not show any significant association between attitude toward medication or treatment adherence and changes in psychiatric symptoms over time. However, after stratification according to baseline severity, we found that both DAI-10 and Kemp's scale negatively predicted changes in BPRS scores at 12-month follow-up regardless of baseline severity. The association at 6-month follow-up was confirmed only in the group with moderate or severe symptoms at baseline.Conclusion: Our findings corroborate the importance of improving the quality of relationship between clinicians and patients. Shared decision making and thorough discussions about benefits and side effects may improve the outcome in patients with severe mental disorders.

Published
2021

29. Resilience, Cardiological Outcome, and Their Correlations With Anxious-Depressive Symptoms and Quality of Life in Patients With an Implantable Cardioverter Defibrillator

Author

Isella, Celeste, primary, Gasparini, Alessandra, additional, Lucca, Giulia, additional, Ielmini, Marta, additional, Caselli, Ivano, additional, Poloni, Nicola, additional, Dajelli Ermolli, Carlo, additional, Caravati, Fabrizio, additional, Castiglioni, Battistina, additional, De Ponti, Roberto, additional, and Callegari, Camilla, additional

Published
2021
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38. 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

Author

Ostuzzi, Giovanni, primary, Gastaldon, Chiara, additional, Barbato, Angelo, additional, D’Avanzo, Barbara, additional, Tettamanti, Mauro, additional, Monti, Igor, additional, Aguglia, Andrea, additional, Aguglia, Eugenio, additional, Alessi, Maria Chiara, additional, Amore, Mario, additional, Bartoli, Francesco, additional, Biondi, Massimo, additional, Bortolaso, Paola, additional, Callegari, Camilla, additional, Carrà, Giuseppe, additional, Caruso, Rosangela, additional, Cavallotti, Simone, additional, Crocamo, Cristina, additional, D’Agostino, Armando, additional, De Fazio, Pasquale, additional, Natale, Chiara Di, additional, Giusti, Laura, additional, Grassi, Luigi, additional, Martinotti, Giovanni, additional, Nosé, Michela, additional, Papola, Davide, additional, Purgato, Marianna, additional, Rodolico, Alessandro, additional, Roncone, Rita, additional, Tarsitani, Lorenzo, additional, Turrini, Giulia, additional, Zanini, Elisa, additional, Amaddeo, Francesco, additional, Ruggeri, Mirella, additional, and Barbui, Corrado, additional

Published
2020
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41. Post-traumatic stress following total hysterectomy for benign disease: an observational prospective study.

Author

Casarin, Jvan, Ielmini, Marta, Cromi, Antonella, Laganà, Antonio Simone, Poloni, Nicola, Callegari, Camilla, and Ghezzi, Fabio

Subjects
POST-traumatic stress disorder, POST-traumatic stress, HYSTERECTOMY, LONGITUDINAL method, SCIENTIFIC observation, DEMOGRAPHIC characteristics
Abstract

Purpose: Over the last decade, there has been growing interest in the psychophysical integrity of surgical patients in the context of healthcare events. In the present study, we aimed to evaluate the incidence rate of postoperative distress symptoms, namely post-traumatic stress disorder (PTSD), following total hysterectomy for benign disease. We also investigated possible associations between sociodemographic characteristics, clinical outcomes, anxiety, depression, and PTSD.Methods: We prospectively enrolled 100 consecutive patients who underwent total hysterectomy for benign disease between 01/01/2019 and 15/04/2019. Demographic and surgical-related characteristics have been registered. The Hospital Anxiety and Depression Scale (HADS) questionnaire was administered preoperatively (Time1), postoperatively (Time2), and at follow-up clinical evaluation, between two and three months after surgery (Time3). PTSD was defined based on the results of the Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) at Time3.Results: At Time3, the median PCL-5 score was 12,8 (0-70), and 16.4% of patients had PTSD symptoms (PCL-5 > 33). No correlation between sociodemographic or gynecologic characteristics and PTSD was detected. A significant association between depression (HADS > 8) at Time2 (p = 0.002) and Time3 (p < 0.001) and PTSD symptoms was shown.Conclusion: Hysterectomy for benign disease is associated with a non-negligible risk of PTDS; the use of the HADS questionnaires might be useful to select patients who might benefit from dedicated psychological support. [ABSTRACT FROM AUTHOR]

Published
2022
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42. Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study

Author

Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D’Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Ostuzzi, Giovanni, Nose, Michela, Purgato, Marianna, Turrini, Giulia, Mazzi, Maria, Angela, Papola, Davide, Gastaldon, Chiara, Terlizzi, Samira, Piccoli, Alberto, Ruggeri, Mirella, De Fazio, Pasquale, Magliocco, Fabio, Caroleo, Mariarita, Raffaele, Gaetano, D'Agostino, Armando, Ostinelli, Edoardo, Giuseppe, Chirico, Margherita, Cavallotti, Simone, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua, Maria, Cerretini, Massimiliano, Tozzi, Fiorella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Zizolfi, Daniele, Poloni, Nicola, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Emanuele, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Bortolaso, Paola, Piccinelli, Marco, Cazzamalli, Sara, Caterina, Alberini, Gabro, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti Silva, Veronica, Papalini, Alessandro, Corbo, Mariangela, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria, Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Carra, Giuseppe, Tabacchi, Tommaso, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora, Tremolada, Martina, Castagna, Gloria, Bava, Mattia, Verrengia, Enrica, Lucchi, Sara, Oriani, Maria, Ginevra, Barchiesi, Michela, Pacetti, Monica, Aguglia, Andrea, Magni, Laura, Rosa, Rossi, Giuseppe, Beneduce, Rossella, Tura, Giovanni, Battista, Laffranchini, Laura, Ferrato, Farida, Restaino, Francesco, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo, Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Di Benedetto, Rossella, Pinna, Federica, Carpiniello, Bernardo, Spano, Mariangela, Giacomin, Marzio, Pecile, Damiano, Mattei, Chiara, Fabrici, Elisabetta, Pascolo, Panarello, Sofia, Peresson, Giulia, Vitucci, Claudio, Bonavigo, Tommaso, Perini, Giovanni, Boschello, Filippo, Strizzolo, Stefania, Gardellin, Francesco, Di Giannantonio, Massimo, Fizzotti, Carlo, Cossetta, Edoardo, Di Gregorio, Luana, Sozzi, Francesca, Boncompagni, Giancarlo, La Barbera, Daniele, Colli, Giuseppe, Laurenzi, Sabrina, Luca, Maria, Crocamo, Carlo, Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, and Ostuzzi, G

Subjects
medicine.medical_specialty, psychiatric practice, lcsh:RC435-571, Treatment adherence, viruses, medicine.medical_treatment, antipsychotic, long-acting injectable, prescribing attitudes, survey, immune system diseases, lcsh:Psychiatry, medicine, Psychiatry, Antipsychotic, prescribing attitude, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Original Research, business.industry, lcsh:RM1-950, virus diseases, lcsh:Therapeutics. Pharmacology, Long acting, Psychology (miscellaneous), business
Abstract

Background: Long acting injectable (LAI) antipsychotics have been claimed to ensure treatment adherence and possibly reduce the daily burden of oral formulations. So far, only surveys investigating the theoretical prescribing attitudes of clinicians have been employed. On this basis, we aimed to investigate reasons for prescribing LAIs in a real-world, unselected sample of patients. Methods: The STAR Network Depot Study is an observational, multicentre study consecutively enrolling adults initiating a LAI over a 12-months period. Clinical severity was assessed with the Brief Psychiatric Rating Scale, and patient’s attitude toward medications with the Drug Attitude Inventory 10 items. Psychiatrists recorded reasons for LAI prescribing for each study participant. Responses were grouped into six non-mutually exclusive categories: aggressiveness, patient engagement, ease of drug taking, side-effects, stigma, adherence. Results: Of the 451 patients included, two-thirds suffered from chronic psychoses. Improving patient engagement with the outpatient psychiatric service was the most common reason for prescribing LAIs (almost 80% of participants), followed by increasing treatment adherence (57%), decreasing aggressiveness (54%), and improving ease of drug taking (52%). After adjusting for confounders, logistic regression analyses showed that reasons for LAI use were associated with LAI choice (e.g. first-generation LAIs for reducing aggressiveness). Conclusion: Despite the wide availability of novel LAI formulation and the emphasis on their wider use, our data suggest that the main reasons for LAI use have remained substantially unchanged over the years, focusing mostly on improving patient’s engagement. Further, clinicians follow implicit prescribing patterns when choosing LAIs, and this may generate hypotheses for future experimental studies.

Published
2020

44. Additional file 1 of 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

Author

Ostuzzi, Giovanni, Gastaldon, Chiara, Barbato, Angelo, D’Avanzo, Barbara, Tettamanti, Mauro, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Alessi, Maria Chiara, Amore, Mario, Bartoli, Francesco, Biondi, Massimo, Bortolaso, Paola, Callegari, Camilla, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Crocamo, Cristina, D’Agostino, Armando, Fazio, Pasquale De, Natale, Chiara Di, Giusti, Laura, Grassi, Luigi, Martinotti, Giovanni, Nosé, Michela, Papola, Davide, Purgato, Marianna, Rodolico, Alessandro, Roncone, Rita, Tarsitani, Lorenzo, Turrini, Giulia, Zanini, Elisa, Amaddeo, Francesco, Ruggeri, Mirella, and Barbui, Corrado

Abstract

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2020
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45. Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study

Author

Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, Ostuzzi, G, Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D'Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Ostuzzi, Giovanni, Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, Ostuzzi, G, Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D'Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, and Ostuzzi, Giovanni

Abstract

Background: Long acting injectable (LAI) antipsychotics have been claimed to ensure treatment adherence and possibly reduce the daily burden of oral formulations. So far, only surveys investigating the theoretical prescribing attitudes of clinicians have been employed. On this basis, we aimed to investigate reasons for prescribing LAIs in a real-world, unselected sample of patients. Methods: The STAR Network Depot Study is an observational, multicentre study consecutively enrolling adults initiating a LAI over a 12-months period. Clinical severity was assessed with the Brief Psychiatric Rating Scale, and patient’s attitude toward medications with the Drug Attitude Inventory 10 items. Psychiatrists recorded reasons for LAI prescribing for each study participant. Responses were grouped into six non-mutually exclusive categories: aggressiveness, patient engagement, ease of drug taking, side-effects, stigma, adherence. Results: Of the 451 patients included, two-thirds suffered from chronic psychoses. Improving patient engagement with the outpatient psychiatric service was the most common reason for prescribing LAIs (almost 80% of participants), followed by increasing treatment adherence (57%), decreasing aggressiveness (54%), and improving ease of drug taking (52%). After adjusting for confounders, logistic regression analyses showed that reasons for LAI use were associated with LAI choice (e.g. first-generation LAIs for reducing aggressiveness). Conclusion: Despite the wide availability of novel LAI formulation and the emphasis on their wider use, our data suggest that the main reasons for LAI use have remained substantially unchanged over the years, focusing mostly on improving patient’s engagement. Further, clinicians follow implicit prescribing patterns when choosing LAIs, and this may generate hypotheses for future experimental studies.

Published
2020

46. 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

Author

Ostuzzi, G, Gastaldon, C, Barbato, A, D'Avanzo, B, Tettamanti, M, Monti, I, Aguglia, A, Aguglia, E, Alessi, M, Amore, M, Bartoli, F, Biondi, M, Bortolaso, P, Callegari, C, Carrà, G, Caruso, R, Cavallotti, S, Crocamo, C, D'Agostino, A, De Fazio, P, Di Natale, C, Giusti, L, Grassi, L, Martinotti, G, Nose, M, Papola, D, Purgato, M, Rodolico, A, Roncone, R, Tarsitani, L, Turrini, G, Zanini, E, Amaddeo, F, Ruggeri, M, Barbui, C, Ostuzzi G., Gastaldon C., Barbato A., D'avanzo B., Tettamanti Mauro, Monti Igor, Aguglia A., Aguglia E., Alessi M. C., Amore M., Bartoli F., Biondi Massimo, Bortolaso P., Callegari Camilla, Carrà G., Caruso R., Cavallotti S., Crocamo C., D'agostino A., De Fazio P., Di Natale C., Giusti Laura, Grassi Luigi, Martinotti Giovanni, Nose M., Papola D., Purgato M., Rodolico A., Roncone R., Tarsitani L., Turrini G., Zanini E., Amaddeo F., Ruggeri Mirella, Barbui C., Ostuzzi, G, Gastaldon, C, Barbato, A, D'Avanzo, B, Tettamanti, M, Monti, I, Aguglia, A, Aguglia, E, Alessi, M, Amore, M, Bartoli, F, Biondi, M, Bortolaso, P, Callegari, C, Carrà, G, Caruso, R, Cavallotti, S, Crocamo, C, D'Agostino, A, De Fazio, P, Di Natale, C, Giusti, L, Grassi, L, Martinotti, G, Nose, M, Papola, D, Purgato, M, Rodolico, A, Roncone, R, Tarsitani, L, Turrini, G, Zanini, E, Amaddeo, F, Ruggeri, M, Barbui, C, Ostuzzi G., Gastaldon C., Barbato A., D'avanzo B., Tettamanti Mauro, Monti Igor, Aguglia A., Aguglia E., Alessi M. C., Amore M., Bartoli F., Biondi Massimo, Bortolaso P., Callegari Camilla, Carrà G., Caruso R., Cavallotti S., Crocamo C., D'agostino A., De Fazio P., Di Natale C., Giusti Laura, Grassi Luigi, Martinotti Giovanni, Nose M., Papola D., Purgato M., Rodolico A., Roncone R., Tarsitani L., Turrini G., Zanini E., Amaddeo F., Ruggeri Mirella, and Barbui C.

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 2016/6

Published
2020

49. Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly with Major Depression. Study Protocol of the Vespa Study: A Pragmatic, Multicentre, Open-Label, Parrallel-Group, Superiority, Randomized Trial

Author

Ostuzzi, Giovanni, primary, Gastaldon, Chiara, additional, Barbato, Angelo, additional, D’Avanzo, Barbara, additional, Tettamanti, Mauro, additional, Monti, Igor, additional, Aguglia, Andrea, additional, Aguglia, Eugenio, additional, Alessi, Maria Chiara, additional, Amore, Mario, additional, Bartoli, Francesco, additional, Biondi, Massimo, additional, Bortolaso, Paola, additional, Callegari, Camilla, additional, Carrà, Giuseppe, additional, Caruso, Rosangela, additional, Cavallotti, Simone, additional, Crocamo, Cristina, additional, D’Agostino, Armando, additional, De Fazio, Pasquale, additional, Natale, Chiara Di, additional, Giusti, Laura, additional, Grassi, Luigi, additional, Martinotti, Giovanni, additional, Nosé, Michela, additional, Papola, Davide, additional, Purgato, Marianna, additional, Rodolico, Alessandro, additional, Roncone, Rita, additional, Tarsitani, Lorenzo, additional, Turrini, Giulia, additional, Zanini, Elisa, additional, Amaddeo, Francesco, additional, Ruggeri, Mirella, additional, and Barbui, Corrado, additional

Published
2019
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