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14 results on '"Gastaldon, C."'

1. Neonatal withdrawal syndrome following in utero exposure to antidepressants: a disproportionality analysis of VigiBase, the WHO spontaneous reporting database

Author

Gastaldon, C, Arzenton, E, Raschi, E, Spigset, O, Papola, D, Ostuzzi, G, Moretti, U, Trifirò, G, Barbui, C, Schoretsanitis, G, and University of Zurich

Subjects
poor neonatal adaptation syndrome, Psychiatry and Mental health, 10054 Clinic for Psychiatry, Psychotherapy, and Psychosomatics, antidepressants, Abstinence syndrome, 610 Medicine & health, pregnancy, neonates, withdrawal syndrome, Applied Psychology
Abstract

Background Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitor (SSRIs). Methods In our case/non-case pharmacovigilance study, based on VigiBase®, the WHO database of suspected adverse drug reactions, we estimated reporting odds ratio (ROR) and the Bayesian information component (IC) with 95% confidence/credibility intervals (CI) as measures of disproportionate reporting of antidepressant-related neonatal withdrawal syndrome. Antidepressants were first compared to all other medications, then to methadone, and finally within each class of antidepressants: SSRIs, tricyclics (TCA) and other antidepressants. Antidepressants were ranked in terms of clinical priority, based on semiquantitative score ratings. Serious v. non-serious reports were compared. Results A total of 406 reports of neonatal withdrawal syndrome in 379 neonates related to 15 antidepressants were included. Disproportionate reporting was detected for antidepressants as a group as compared to all other drugs (ROR: 6.18, 95% CI 5.45–7.01, IC: 2.07, 95% CI 1.92–2.21). Signals were found for TCAs (10.55, 95% CI 8.02–13.88), followed by other antidepressants (ROR: 5.90, 95% CI 4.74–7.36) and SSRIs (ROR: 4.68, 95% CI 4.04–5.42). Significant disproportionality emerged for all individual antidepressants except for bupropion, whereas no disproportionality for any antidepressant was detected v. methadone. Eleven antidepressants had a moderate clinical priority score and four had a weak one. Most frequent symptoms included respiratory symptoms (n = 106), irritability/agitation (n = 75), tremor (n = 52) and feeding problems (n = 40). Conclusions Most antidepressants are associated with moderate signals of disproportionate reporting for neonatal withdrawal syndrome, which should be considered when prescribing an antidepressant during pregnancy, irrespective of class.

Published
2022

2. Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Author

Bertolini, F., Ostuzzi, G., Pievani, M., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carra, G., Corbo, M., D'Agostino, A., De Fazio, P., Magliocco, F., Martinotti, G., Ostinelli, E. G., Piccinelli, M. P., Tedeschi, F., Barbui, C., Boschello, F., Gastaldon, C., Mazzi, M. A., Nose, M., Papola, D., Perini, G., Piccoli, A., Purgato, M., Ruggeri, M., Terlizzi, S., Turrini, G., Raffaele, G., Cavallotti, S., Chirico, M., Ferrato, F., Limosani, I., Mastromo, D., Monzani, E., 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., Callegred, C., Calzolari, R., Caselli, I., Diurni, M., Giana, E., Ielmini, M., Milano, A., Poloni, N., Sani, E., Zizolfi, D., Alberini, G., 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., Campese, O., 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., Pacetti, M., 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., Gardellin, F., Strizzolo, S., Cossetta, E., Fizzotti, C., Moretti, D., Di Gregorio, L., Sozzi, F., Colli, G., La Barbera, D., Laurenzi, S., Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, 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, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, 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, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E.G., Piccinelli M.P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M.A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., 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., Callegred C., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., 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., Campese O., 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., Pacetti M., 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., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., and Laurenzi S.

Subjects
Male, Pediatrics, respectively), 0302 clinical medicine, Delayed-Action Preparation, Brief Psychiatric Rating Scale, Pharmacology (medical), he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, Original Research Article, Prospective Studies, Prospective cohort study, treatment, Mental Disorders, Hazard ratio, whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, Psychiatric Status Rating Scale, Middle Aged, side efects, Psychiatry and Mental health, Italy, Mental Disorder, Female, he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, occurring in almost 40% of the entire sample, side efects, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, respectively), whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, respectively). In multivariate analysis, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Human, Antipsychotic Agents, medicine.drug, Psychopathology, Adult, medicine.medical_specialty, Discontinuation, Follow-Up Studie, Medication Adherence, 03 medical and health sciences, medicine, Humans, Paliperidone, Adverse effect, Settore MED/25 - Psichiatria, discontinuation rates, Psychiatric Status Rating Scales, respectively). In multivariate analysis, business.industry, Long-Acting Antipsychotic, long-acting injectable antipsychotics, Survival Analysis, Confidence interval, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, 030227 psychiatry, Prospective Studie, Antipsychotic Agent, occurring in almost 40% of the entire sample, Delayed-Action Preparations, Neurology (clinical), business, 030217 neurology & neurosurgery, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Follow-Up Studies
Abstract

Background Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00809-w.

Published
2021

3. Clinical correlates of paliperidone palmitate and aripiprazole monohydrate prescription for subjects with schizophreniaspectrum disorders: Findings from the STAR Network Depot Study

Author

Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, 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 SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, 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, Carrà G, Bartoli F, 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 MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, 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, Crocamo C, STAR Network Depot Investigators, Bartoli F., Ostuzzi G., Crocamo C., Corbo M., D'Agostino A., Martinotti G., Ostinelli E.G., Tabacchi T., Barbui C., Carr 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., Chirico M., Cavallotti S., 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., Papalini A., 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., Carra G., 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., Aguglia A., 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., Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, 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 SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, 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, Carrà G, Bartoli F, 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 MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, 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, Crocamo C, STAR Network Depot Investigators, Bartoli, F, Ostuzzi, G, Crocamo, C, Corbo, M, D'Agostino, A, Martinotti, G, Ostinelli, E, Tabacchi, T, Barbui, C, and Carra, G

Subjects
Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Adult, Antipsychotic Agents, Aripiprazole, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Medication Adherence, Paliperidone Palmitate, Practice Patterns, Physicians', Schizophrenic Psychology, Young Adult, Long-acting injectable antipsychotic, medicine.medical_specialty, medicine.medical_treatment, Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Practice Patterns, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Brief Psychiatric Rating Scale, medicine, Pharmacology (medical), Antipsychotic, Settore MED/25 - Psichiatria, Practice, Physicians', business.industry, Health Knowledge, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Attitudes, Propensity score matching, Observational study, business, 030217 neurology & neurosurgery, medicine.drug, Psychopathology
Abstract

This study, based on the 'Servizi Territoriali Associati per la Ricerca' (STAR) Network Depot Study nationwide baseline data, explored whether individual symptoms severity and clusters might influence the prescription of paliperidone palmitate 1-month (PP1M) vs. aripiprazole monohydrate. The Brief Psychiatric Rating Scale (BPRS) was used to assess psychopathology and relevant symptoms clusters. Drug Attitude Inventory, 10 items, was used to test attitude towards medications. Adherence to treatments was rated according to the Kemp seven-point scale. We assessed for eligibility 451 individuals and, among them, we included 195 subjects (n = 117 who started PPM1 and n = 78 aripiprazole monohydrate). Individuals were comparable in terms of age, gender, treatment years, recent hospitalizations, previous long-acting injectable antipsychotic treatments, additional oral treatments, attitude toward drugs, medication adherence, and alcohol/substance-related comorbidities. Subjects starting PP1M presented higher BPRS overall (P = 0.009), positive (P = 0.015), and negative (P = 0.010) symptom scores compared to subjects starting aripiprazole monohydrate. Results were confirmed by appropriate regression models and propensity score matching analysis. No differences were found comparing the other BPRS subscale scores: affect, resistance, and activation. Clinicians may be more prone to prescribe PPM1, rather than aripiprazole monohydrate, to subjects showing higher overall symptom severity, including positive and negative symptoms. No additional clinical factors influenced prescribing attitudes in our sample.

Published
2020

4. Erratum: Safety of psychotropic medications in people with COVID-19: Evidence review and practical recommendations (BMC Medicine (2020) 18 (215) DOI: 10.1186/s12916-020-01685-9)

Author

Ostuzzi, G., Papola, D., Gastaldon, C., Schoretsanitis, G., Bertolini, F., Amaddeo, F., Cuomo, A., Emsley, R., Fagiolini, A., Imperadore, G., Kishimoto, T., Michencigh, G., Nose, M., Purgato, M., Dursun, S., Stubbs, B., Taylor, D., Thornicroft, G., Ward, P. B., Hiemke, C., Correll, C. U., and Barbui, C.

Published
2020

5. Factors associated with first- versus second-generation long-acting antipsychotics prescribed under ordinary clinical practice in Italy

Author

Ostuzzi, G., Mazzi, M. A., Terlizzi, S., Bertolini, F., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carrà, G., Corbo, M., D'Agostino, A., Gastaldon, C., Lucii, C., Magliocco, F., Martinotti, G., Nosé, M., Ostinelli, E. G., Papola, D., Piccinelli, M. P., Piccoli, A., Purgato, M., Tabacchi, T., Turrini, G., Ruggeri, M., Barbui, C., De Fazio, P., Raffaele, G., Chirico, M., Cavallotti, S., 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. E., Magnani, N., Cardamone, G., Bardicchia, F., Facchi, E., Soscia, F., Zotos, S., Biancosino, B., Zonta, F., Pompei, F., Zizolfi, D., Poloni, N., Ielmini, M., Caselli, I., Giana, E., Buzzi, A., Diurni, M., Milano, A., Sani, E., Calzolari, Roberta, Cazzamalli, S., Alberini, Gabrio, Piantanida, Silvia, Costantini, C., Paronelli, Chiara, Di Caro, A., Moretti, V., Gozzi, M., D'Ippolito, C., Barbanti, S. V., Alessandro, P., 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., Nava, R., Bono, A., Provenzi, M., Brambilla, G., Aspesi, F., Tremolada, M., Castagna, G., Bava, M., Verrengia, E., Lucchi, S., Oriani, M. G., Barchiesi, M., Pacetti, M., 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., Benedetto, R. D., 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., Gregorio, L. D., Sozzi, F., Boncompagni, G., Barbera, D. L., Colli, G., Laurenzi, S., Calandra, C., Luca, M., Ostuzzi, Giovanni, Mazzi, Maria Angela, Terlizzi, Samira, Bertolini, Federico, Aguglia, Andrea, Bartoli, Francesco, Bortolaso, Paola, Callegari, Camilla, Caroleo, Mariarita, Carrà, Giuseppe, Corbo, Mariangela, D'Agostino, Armando, Gastaldon, Chiara, Lucii, Claudio, Magliocco, Fabio, Martinotti, Giovanni, Nosé, Michela, Ostinelli, Edoardo Giuseppe, Papola, Davide, Piccinelli, Marco Piero, Piccoli, Alberto, Purgato, Marianna, Tabacchi, Tommaso, Turrini, Giulia, Ruggeri, Mirella, Barbui, Corrado, De Fazio, Pasquale, Raffaele, Gaetano, 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, Fior-Ella, 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, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Piccinelli, Marco, Cazzamalli, Sara, Alberini, Gabrio, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti, Silva Veronica, Alessandro, Papalini, 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, 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, Mastromo, Daniele, Ferrato, Farida, Restaino, Francesco, Monzani, Emiliano, Porcellana, Matteo, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Benedetto, Rossella Di, 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, Moretti, Daniele, Fizzotti, Carlo, Cossetta, Edoardo, Gregorio, Luana Di, Sozzi, Francesca, Boncompagni, Giancarlo, Barbera, Daniele La, Colli, Giuseppe, Laurenzi, Sabrina, Calandra, Carmela, Luca, Maria, Ostuzzi, G, Mazzi, M, Terlizzi, S, Bertolini, F, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carrà, G, Corbo, M, D'Agostino, A, Gastaldon, C, Lucii, C, Magliocco, F, Martinotti, G, Nosé, M, Ostinelli, E, Papola, D, Piccinelli, M, Piccoli, A, Purgato, M, Tabacchi, T, Turrini, G, Ruggeri, M, Barbui, C, De Fazio, P, Raffaele, G, Chirico, M, Cavallotti, S, Bolognesi, S, Debolini, S, Pierantozzi, E, Fargnoli, F, Del Zanna, M, Giannini, A, Luccarelli, L, De Capua, A, Annese, P, Cerretini, M, Tozzi, F, Magnani, N, Cardamone, G, Bardicchia, F, Facchi, E, Soscia, F, Zotos, S, Biancosino, B, Zonta, F, Pompei, F, Zizolfi, D, Poloni, N, Ielmini, M, Caselli, I, Giana, E, Buzzi, A, Diurni, M, Milano, A, Sani, E, Calzolari, R, Cazzamalli, S, Alberini, G, Piantanida, S, Costantini, C, Paronelli, C, Di Caro, A, Moretti, V, Gozzi, M, D'Ippolito, C, Barbanti, S, Alessandro, P, Campese, O, Fiori, F, Lorusso, M, Di Capro, L, Viceconte, D, Mancini, V, Suraniti, F, Signorelli, M, 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, Nava, R, Bono, A, Provenzi, M, Brambilla, G, Aspesi, F, Tremolada, M, Castagna, G, Bava, M, Verrengia, E, Lucchi, S, Oriani, M, Barchiesi, M, Pacetti, M, Magni, L, Rossi, G, Beneduce, R, Tura, G, Laffranchini, L, Mastromo, D, Ferrato, F, Restaino, F, Monzani, E, Porcellana, M, Limosani, I, Ghio, L, Ferro, M, Parise, V, Balletta, G, Addeo, L, De Vivo, E, Benedetto, R, Pinna, F, Carpiniello, B, Spano, M, Giacomin, M, Pecile, D, Mattei, C, Fabrici, E, 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, Gregorio, L, Sozzi, F, Boncompagni, G, Barbera, D, Colli, G, Laurenzi, S, Calandra, C, and Luca, M

Subjects
Genetics and Molecular Biology (all), Male, Pediatrics, European People, Bipolar Disorder, Cross-sectional study, Economics, Epidemiology, medicine.medical_treatment, assessment, viruses, lcsh:Medicine, Social Sciences, Longitudinal Studie, Biochemistry, Prescription, Geographical locations, 0302 clinical medicine, Mathematical and Statistical Techniques, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), immune system diseases, Medicine and Health Sciences, long-acting intramuscular (LAI) antipsychotics, clinical practice, second-generation antipsychotic (SGA) LAIs, Antipsychotics, Ethnicities, Longitudinal Studies, lcsh:Science, Multidisciplinary, virus diseases, Drugs, Middle Aged, Italian People, Europe, Prescriptions, Italy, Physical Sciences, Aripiprazole, Female, Bivariate Analysis, Statistics (Mathematics), medicine.drug, Human, Research Article, Antipsychotic Agents, Employment, Adult, medicine.medical_specialty, Adolescent, Research and Analysis Methods, 03 medical and health sciences, Mental Health and Psychiatry, medicine, Humans, Paliperidone, Bipolar disorder, European Union, Statistical Methods, Antipsychotic, Cross-Sectional Studie, Pharmacology, Risperidone, business.industry, Mood Disorders, lcsh:R, medicine.disease, 030227 psychiatry, Antipsychotic Agent, Cross-Sectional Studies, Labor Economics, Multivariate Analysis, Schizophrenia, Observational study, lcsh:Q, Population Groupings, People and places, business, 030217 neurology & neurosurgery, Mathematics
Abstract

Background For many years, long-acting intramuscular (LAI) antipsychotics have been prescribed predominantly to chronic and severe patients, as a last resort when other treatments failed. Recently, a broader and earlier use of LAIs, particularly second-generation LAIs, has been emphasized. To date, few studies attempted to frame how this change in prescribing took place in real-world practice. Therefore, this study aimed to describe the clinical features of patients prescribed with LAIs, and to explore possible prescribing differences between first- and second-generations LAIs under ordinary clinical practice in Italy. Methods The STAR Network "Depot" Study is an observational, longitudinal, multicenter study involving 35 centers in Italy. In the cross-sectional phase, patients prescribed with LAIs were consecutively recruited and assessed over a period of 12 months. Descriptive statistics and multivariable logistic regression analyses were employed. Results Of the 451 recruited patients, 61% were males. The level of social and working functioning was heterogeneous, as was the severity of disease. Seventy-two per cent of the patients had a diagnosis of the schizophrenia spectrum. Seventy per cent were prescribed with second-generation antipsychotic (SGA) LAIs (mostly paliperidone, aripiprazole and risperidone). Compared to first-generation antipsychotic (FGA) LAIs, patients prescribed with SGA LAIs were more often younger; employed; with a diagnosis of the schizophrenia spectrum or bipolar disorder; with higher levels of affective symptoms; with fewer LAI prescriptions in the past. Discussion LAIs' prescribing practices appear to be more flexible as compared to the past, although this change is mostly restricted to SGA LAIs.

Published
2018

6. Antipsychotic dose mediates the association between polypharmacy and corrected QT interval

Author

Barbui, Corrado, Bighelli, Irene, Carrà, Giuseppe, Castellazzi, Mariasole, Lucii, Claudio, Martinotti, Giovanni, Nosè, Michela, Ostuzzi, Giovanni, Acciavatti, T., Adamo, A., Aguglia, A., Albanese, C., Baccaglini, S., Bardicchia, F., Barone, R., Barone, Y., Bartoli, F., Bergamini, C., Bertolini, F., Bolognesi, S., Bordone, A., Bortolaso, P., Bugliani, M., Calandra, C., Calò, S., Cardamone, G., Caroleo, M., Carra, E., Car-Retta, D., Chiocchi, L., Cinosi, E., Clerici, M., Corbo, M., Corsi, E., Costanzo, R., Costoloni, G., D'Arienzo, F., Debolini, S., De Capua, A., Di Napoli, W. A., Dinelli, M., Facchi, E., Fargnoli, F., Fiori, F., Franchi, A., Gardellin, F., Gastaldon, C., Gazzoletti, E., Ghio, L., Giacomin, M., Gregis, M., Iovieno, N., Koukouna, D., Lax, A., Lintas, C., Luca, A., Luca, M., Lussetti, M., Madrucci, M., Magnani, N., Magni, L., Manca, E., Martorelli, C., Mattafirri, R., Paladini, C., Papola, D., Percudani, M., Perini, G., Petrosemolo, P., Pezzullo, M., Piantanida, S., Pinna, F., Prato, K., Prestia, D., Quattrone, D., Reggianini, C., Restaino, F., Ribolsi, M., Rinosi, G., Rizzo, C., Rizzo, R., Roggi, M., Rossi, G., Rossi, S., Ruberto, S., Santi, M., Santoro, R., Sepede, G., Signorelli, M. S., Soscia, F., Sozzi, F., Staffa, P., Stilo, M., Strizzolo, S., Suraniti, F., Tavian, N., Tortelli, L., Tosoni, F., Valdagno, M., Zanobini, V., Barbui, C, Bighelli, I, Carrà, G, Castellazzi, M, Lucii, C, Martinotti, G, Nosè, M, Ostuzzi, G, Acciavatti, T, Adamo, A, Aguglia, A, Albanese, C, Baccaglini, S, Bardicchia, F, Barone, R, Barone, Y, Bartoli, F, Bergamini, C, Bertolini, F, Bolognesi, S, Bordone, A, Bortolaso, P, Bugliani, M, Calandra, C, Calò, S, Cardamone, G, Caroleo, M, Carra, E, Carretta, D, Chiocchi, L, Cinosi, E, Clerici, M, Corbo, M, Corsi, E, Costanzo, R, Costoloni, G, D'Arienzo, F, Debolini, S, De Capua, A, Di Napoli, W, Dinelli, M, Facchi, E, Fargnoli, F, Fiori, F, Franchi, A, Gardellin, F, Gastaldon, C, Gazzoletti, E, Ghio, L, Giacomin, M, Gregis, M, Iovieno, N, Koukouna, D, Lax, A, Lintas, C, Luca, A, Luca, M, Lussetti, M, Madrucci, M, Magnani, N, Magni, L, Manca, E, Martorelli, C, Mattafirri, R, Paladini, C, Papola, D, Percudani, M, Perini, G, Petrosemolo, P, Pezzullo, M, Piantanida, S, Pinna, F, Prato, K, Prestia, D, Quattrone, D, Reggianini, C, Restaino, F, Ribolsi, M, Rinosi, G, Rizzo, C, Rizzo, R, Roggi, M, Rossi, G, Rossi, S, Ruberto, S, Santi, M, Santoro, R, Sepede, G, Signorelli, M, Soscia, F, Sozzi, F, Staffa, P, Stilo, M, Strizzolo, S, Suraniti, F, Tavian, N, Tortelli, L, Tosoni, F, Valdagno, M, and Zanobini, V

Subjects
Male, Genetics and Molecular Biology (all), medicine.medical_treatment, Aripiprazole, lcsh:Medicine, Pharmacology, Cardiovascular Medicine, dose-dependent risk, Biochemistry, Electrocardiography, 0302 clinical medicine, Heart Rate, Medicine and Health Sciences, 80 and over, Antipsychotics, lcsh:Science, Aged, 80 and over, Multidisciplinary, Pharmaceutics, Medicine (all), Mental Disorders, Confounding, Drug Information, Drugs, Middle Aged, Long QT Syndrome, Bioassays and Physiological Analysis, Italy, Cardiovascular Diseases, Cardiology, Female, QT interval corrected for heart rate, Adult, Aged, Antipsychotic Agents, Cross-Sectional Studies, Dose-Response Relationship, Drug, Haloperidol, Humans, Young Adult, Polypharmacy, Agricultural and Biological Sciences (all), medicine.drug, Research Article, medicine.medical_specialty, Patients, QTc lenghtening, therapy risk, Long QT syndrome, antipsychotic drugs, Research and Analysis Methods, polypharmacy, QT interval, 03 medical and health sciences, Dose Prediction Methods, Drug Therapy, Internal medicine, Dose-Response Relationship, Drug, Biochemistry, Genetics and Molecular Biology (all), Heart rate, medicine, Antipsychotic, Inpatients, business.industry, lcsh:R, Electrophysiological Techniques, medicine.disease, 030227 psychiatry, Health Care, Defined daily dose, Settore MED/25, lcsh:Q, Cardiac Electrophysiology, business, 030217 neurology & neurosurgery
Abstract

Antipsychotic (AP) drugs have the potential to cause prolongation of the QT interval corrected for heart rate (QTc). As this risk is dose-dependent, it may be associated with the number of AP drugs concurrently prescribed, which is known to be associated with increased cumulative equivalent AP dosage. This study analysed whether AP dose mediates the relationship between polypharmacy and QTc interval. We used data from a cross-sectional survey that investigated the prevalence of QTc lengthening among people with psychiatric illnesses in Italy. AP polypharmacy was tested for evidence of association with AP dose and QTc interval using the Baron and Kenny mediational model. A total of 725 patients were included in this analysis. Of these, 186 (26%) were treated with two or more AP drugs (AP polypharmacy). The mean cumulative AP dose was significantly higher in those receiving AP polypharmacy (prescribed daily dose/defined daily dose = 2.93, standard deviation 1.31) than monotherapy (prescribed daily dose/defined daily dose = 0.82, standard deviation 0.77) (z = -12.62, p < 0.001). Similarly, the mean QTc interval was significantly longer in those receiving AP polypharmacy (mean = 420.86 milliseconds, standard deviation 27.16) than monotherapy (mean = 413.42 milliseconds, standard deviation 31.54) (z = -2.70, p = 0.006). The Baron and Kenny mediational analysis showed that, after adjustment for confounding variables, AP dose mediates the association between polypharmacy and QTc interval. The present study found that AP polypharmacy is associated with QTc interval, and this effect is mediated by AP dose. Given the high prevalence of AP polypharmacy in real-world clinical practice, clinicians should consider not only the myriad risk factors for QTc prolongation in their patients, but also that adding a second AP drug may further increase risk as compared with monotherapy.

Published
2016

7. First-generation antipsychotics and QTc: any role for mediating variables?

Author

Carrà, G., Crocamo, Cristina, Bartoli, F., Lax, A., Tremolada, Martina, Lucii, C., Martinotti, G., Nosè, M., Bighelli, I., Ostuzzi, G., Castellazzi, M., Clerici, M., Barbui, C., Acciavatti, T., Adamo, A., Aguglia, A., Albanese, C., Baccaglini, S., Bardicchia, F., Barone, R., Barone, Y., Bergamini, C., Bertolini, F., Bolognesi, S., Bordone, A., Bortolaso, P., Bugliani, M., Calandra, C., Calò, S., Cardamone, G., Caroleo, M., Carra, E., Carretta, D., Chiocchi, L., Cinosi, E., Corbo, M., Corsi, E., Costanzo, R., Costoloni, G., D’Arienzo, F., Debolini, S., De Capua, A., Di Napoli, W. A., Dinelli, M., Facchi, E., Fargnoli, F., Fiori, F., Franchi, A., Gardellin, F., Gastaldon, C., Gazzoletti, E., Ghio, L., Giacomin, M., Gregis, M., Iovieno, N., Koukouna, D., Lintas, C., Luca, A., Luca, M., Lussetti, M., Madrucci, M., Magnani, N., Magni, L., Manca, E., Martorelli, C., Mattafirri, R., Paladini, C., Papola, D., Percudani, M., Perini, G., Petrosemolo, P., Pezzullo, M., Piantanida, S., Pinna, F., Prato, K., Prestia, D., Quattrone, D., Reggianini, C., Restaino, F., Ribolsi, M., Rinosi, G., Rizzo, C., Rizzo, R., Roggi, M., Rossi, G., Rossi, S., Ruberto, S., Santi, M., Santoro, R., Sepede, G., Signorelli, M. S., Soscia, F., Sozzi, F., Staffa, P., Stilo, M., Strizzolo, S., Suraniti, F., Tavian, N., Tortelli, L., Tosoni, F., Valdagno, M., Zanobini, V., Carra', G, Crocamo, C, Bartoli, F, Lax, A, Tremolada, M, Lucii, C, Martinotti, G, Nosè, M, Bighelli, I, Ostuzzi, G, Castellazzi, M, Clerici, M, and Barbui, C

Subjects
Adult, Male, QT prolongation, alcohol, antipsychotic agents, drug therapy combination, risk factors, Antipsychotic Agents, Cross-Sectional Studies, Electrocardiography, Female, Heart Rate, Humans, Italy, Long QT Syndrome, Mental Disorders, Middle Aged, Pharmacology (medical), Settore MED/25 - Psichiatria, Neurology, Neurology (clinical), Psychiatry and Mental Health, antipsychotic agent, risk factor
Abstract

Objective: Corrected QT (QTc) interval prolongation is often associated with use of first-generation antipsychotics (FGAs). However, other factors require appropriate consideration, including age and gender, the role of other known medications associated with QTc prolongation, and severe comorbid conditions, such as co-occurring alcohol abuse/dependence. We aimed to study potential mediating roles of different, related, candidate variables on QTc. Methods: We capitalized on data from a large (N = 2366), cross-sectional, national survey, the STAR Network QTc study, using a representative sample of people taking FGAs, and recruited from mental health services across Italy. Results: About one-third of the sample was treated with FGAs, and almost one-tenth of the subjects took a different, additional, drug known to cause QTc prolongation. Our findings confirmed that there is an impact from FGAs, age, gender, alcohol misuse, and concurrent risky drugs on QTc. However, comorbid alcohol abuse/dependence and concurrent risky drugs did not mediate the effect of FGAs on QTc. Conclusions: Our findings showed that FGAs, concurrent risky drugs, and alcohol use disorders prolonged QTc. FGAs had a direct effect on QTc, confirming the need for clinicians to monitor a risk that could lead to sudden unexplained death. Copyright © 2016 John Wiley & Sons, Ltd.

Published
2016

8. Clinical trajectories of individuals with severe mental illness continuing and discontinuing long-acting antipsychotics: a one-year mirror-image analysis from the STAR Network Depot study

Author

Giovanni Ostuzzi, Federico Tedeschi, Federico Bertolini, Carlo Cotugno, Andrea Aguglia, Francesco Bartoli, Giuseppe Carrà, Armando D’Agostino, Giovanni Martinotti, Corrado Barbui, Chiara Gastaldon, Davide Papola, Ostuzzi, G, Tedeschi, F, Bertolini, F, Cotugno, C, Aguglia, A, Bartoli, F, Carrà, G, D’Agostino, A, Martinotti, G, Barbui, C, Gastaldon, C, and Papola, D

Subjects
schizophrenia, severe mental illness, clinical outcome, psychosis, long-acting antipsychotics, long-acting antipsychotic
Abstract

Evidence on long-acting antipsychotics (LAIs) in unselected populations with severe mental illness is scant. In this mirror-image study, we compared multiple clinical outcomes 1 year before and after a first LAI prescription in adults with severe mental illness, describing clinical trajectories of LAI continuers and discontinuers. We compared LAI continuers and discontinuers through Mann–Whitney U test, Kaplan–Meier survival curves, regression for interval-censored data, and a maximum-likelihood mixed-model with individual random-effect and time as predictor. Of the 261 participants analyzed, 71.3% had schizophrenia-spectrum disorders, and 29.5% discontinued the LAI before 1 year. At baseline, LAI discontinuers had a shorter illness duration, lower attitude and adherence scores. The mirror-image analysis showed reduced hospital admissions only for LAI continuers. Over time, continuers spent less days hospitalized, but had more adverse events and more antipsychotics prescribed, with higher overall doses. In conclusion, this study shows that LAIs might be beneficial in unselected patient populations, provided that adherence is maintained. LAI continuers spent less time hospitalized, but received more antipsychotics and suffered from more cumulative adverse events over time. Therefore, the choice of initiating and maintaining a LAI should be carefully weighed on a case-by-case basis.

Published
2023

9. 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

10. 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

11. Long-term effectiveness of Self-Help Plus in refugees and asylum seekers resettled in Western Europe:12-month outcomes of a randomised controlled trial

Author

G. Turrini, M. Purgato, F. Tedeschi, C. Acartürk, M. Anttila, T. Au, K. Carswell, R. Churchill, P. Cuijpers, F. Friedrich, C. Gastaldon, T. Klein, M. Kösters, T. Lantta, M. Nosè, G. Ostuzzi, D. Papola, M. Popa, M. Sijbrandij, L. Tarsitani, L. Todini, E. Uygun, M. Välimäki, L. Walker, J. Wancata, R. G. White, E. Zanini, M. van Ommeren, C. Barbui, Clinical Psychology, World Health Organization (WHO) Collaborating Center, APH - Global Health, APH - Mental Health, Acartürk, Zeynep Ceren (ORCID 0000-0001-7093-1554 & YÖK ID 39271), Turrini, G., Purgato, M., Tedeschi, F., Anttila, M., Au, T., Carswell, K., Churchill, R., Cuijpers, P., Friedrich, F., Gastaldon, C., Klein, T., Kosters, M., Lantta, T., Nose, M., Ostuzzi, G., Papola, D., Popa, M., Sijbrandij, M., Tarsitani, L., Todini, L., Uygun, E., Valimaki, M., Walker, L., Wancata, J., White, R. G., Zanini, E., van Ommeren, M., Barbui, C., College of Social Sciences and Humanities, and Department of Psychology

Subjects
Psychiatry, Epidemiology, Mental Disorders, Prevention, Health Behavior, SDG 16 - Peace, Justice and Strong Institutions, Public Health, Environmental and Occupational Health, SDG 10 - Reduced Inequalities, Psychological Distress, refugees, psychosocial intervention, randomised controlled trial, Stress Disorders, Post-Traumatic/psychology, Stress Disorders, Post-Traumatic, Europe, Psychiatry and Mental health, Psychosocial intervention, Randomised controlled trial, Refugees, SDG 3 - Good Health and Well-being, Humans, Refugees/psychology, Mental Disorders/epidemiology
Abstract

Aims: as refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe. Methods: refugees and asylum seekers with psychological distress (General Health Questionnaire-12 > 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes. Results: of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p-value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p-value = 0.230). SH + was associated with improvements at 12 months in psychological distress (p-value = 0.004), depressive symptoms (p-value = 0.011) and wellbeing (p-value = 0.001). Conclusions: the present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence., European Union (EU); Horizon 2020; European Commission; RE-DEFINE: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions

Published
2022

12. Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System

Author

Emanuel Raschi, Georgios Schoretsanitis, Corrado Barbui, John M. Kane, Chiara Gastaldon, Gastaldon C., Raschi E., Kane J.M., Barbui C., and Schoretsanitis G.

Subjects
medicine.medical_specialty, Esketamine, Adverse drug reaction, Adverse drug reactions, Suicidality, 03 medical and health sciences, Adverse Event Reporting System, Pharmacovigilance, 0302 clinical medicine, Internal medicine, Medicine, 030212 general & internal medicine, Adverse effect, Suicidal ideation, Applied Psychology, Polypharmacy, Marketing, Suicide attempt, business.industry, General Medicine, Odds ratio, Confidence interval, 030227 psychiatry, Psychiatry and Mental health, Clinical Psychology, Prospective Studie, Adverse Drug Reaction Reporting System, Female, Ketamine, medicine.symptom, Treatment-resistant depression, business, Drug-Related Side Effects and Adverse Reaction, Human
Abstract

Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. Methods: We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. Results: The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ2 = 125.29, p < 0.001, χ2 = 9.08, p = 0.003, χ2 = 8.14, p = 0.004, χ2 = 19.48, p < 0.001, χ2 = 25.62, p < 0.001, and χ2 = 16.79, p < 0.001, respectively). Conclusions: Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.

Published
2021

13. 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

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

Subjects
medicine.medical_specialty, Medicine (miscellaneous), Antidepressant, Equivalence Trials as Topic, Antidepressants, Depression, Elderly, Pragmatic trial, Randomized clinical trial, Vortioxetine, NO, law.invention, Study Protocol, 03 medical and health sciences, Antidepressants, Depression, Elderly, Pragmatic trial, Randomized clinical trial, Equivalence Trials as Topic, Vortioxetine, Serotonin Uptake Inhibitors, 0302 clinical medicine, Randomized controlled trial, Quality of life, Rating scale, law, Pragmatic Clinical Trials as Topic, medicine, Humans, Multicenter Studies as Topic, Pharmacology (medical), 030212 general & internal medicine, Depression (differential diagnoses), Aged, Depressive Disorder, Major, Depressive Disorder, lcsh:R5-920, business.industry, Major, Guideline, Italy, Serotonin Uptake Inhibitors, Tolerability, Good clinical practice, Physical therapy, lcsh:Medicine (General), business, Selective Serotonin Reuptake Inhibitors, 030217 neurology & neurosurgery
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.

Published
2020

14. Combinations of QTc-prolonging drugs: towards disentangling pharmacokinetic and pharmacodynamic effects in their potentially additive nature

Author

A. D. Meid, I. Bighelli, S. Mächler, G. Mikus, G. Carrà, M. Castellazzi, C. Lucii, G. Martinotti, M. Nosè, G. Ostuzzi, T. Acciavatti, A. Adamo, A. Aguglia, C. Albanese, S. Baccaglini, F. Bardicchia, R. Barone, Y. Barone, F. Bartoli, C. Bergamini, F. Bertolini, S. Bolognesi, A. Bordone, P. Bortolaso, M. Bugliani, C. Calandra, S. Calò, G. Cardamone, M. Caroleo, E. Carra, D. Carretta, L. Chiocchi, E. Cinosi, M. Clerici, M. Corbo, E. Corsi, R. Costanzo, G. Costoloni, F. D’Arienzo, S. Debolini, A. De Capua, W. A. Di Napoli, M. Dinelli, E. Facchi, F. Fargnoli, F. Fiori, A. Franchi, F. Gardellin, C. Gastaldon, E. Gazzoletti, L. Ghio, M. Giacomin, M. Gregis, N. Iovieno, D. Koukouna, A. Lax, C. Lintas, A. Luca, M. Luca, M. Lussetti, M. Madrucci, N. Magnani, L. Magni, E. Manca, C. Martorelli, R. Mattafirri, C. Paladini, D. Papola, M. Percudani, G. Perini, P. Petrosemolo, M. Pezzullo, S. Piantanida, F. Pinna, K. Prato, D. Prestia, D. Quattrone, C. Reggianini, F. Restaino, M. Ribolsi, G. Rinosi, C. Rizzo, R. Rizzo, M. Roggi, G. Rossi, S. Rossi, S. Ruberto, M. Santi, R. Santoro, G. Sepede, M. S. Signorelli, F. Soscia, P. Staffa, M. Stilo, S. Strizzolo, F. Suraniti, N. Tavian, L. Tortelli, F. Tosoni, M. Valdagno, V. Zanobini, C. Barbui, W. E. Haefeli, Meid, A, Bighelli, I, Mächler, S, Mikus, G, Carrà, G, Castellazzi, M, Lucii, C, Martinotti, G, Nosè, M, Ostuzzi, G, Acciavatti, T, Adamo, A, Aguglia, A, Albanese, C, Baccaglini, S, Bardicchia, F, Barone, R, Barone, Y, Bartoli, F, Bergamini, C, Bertolini, F, Bolognesi, S, Bordone, A, Bortolaso, P, Bugliani, M, Calandra, C, Calò, S, Cardamone, G, Caroleo, M, Carra, E, Carretta, D, Chiocchi, L, Cinosi, E, Clerici, M, Corbo, M, Corsi, E, Costanzo, R, Costoloni, G, D’Arienzo, F, Debolini, S, De Capua, A, Di Napoli, W, Dinelli, M, Facchi, E, Fargnoli, F, Fiori, F, Franchi, A, Gardellin, F, Gastaldon, C, Gazzoletti, E, Ghio, L, Giacomin, M, Gregis, M, Iovieno, N, Koukouna, D, Lax, A, Lintas, C, Luca, A, Luca, M, Lussetti, M, Madrucci, M, Magnani, N, Magni, L, Manca, E, Martorelli, C, Mattafirri, R, Paladini, C, Papola, D, Percudani, M, Perini, G, Petrosemolo, P, Pezzullo, M, Piantanida, S, Pinna, F, Prato, K, Prestia, D, Quattrone, D, Reggianini, C, Restaino, F, Ribolsi, M, Rinosi, G, Rizzo, C, Rizzo, R, Roggi, M, Rossi, G, Rossi, S, Ruberto, S, Santi, M, Santoro, R, Sepede, G, Signorelli, M, Soscia, F, Staffa, P, Stilo, M, Strizzolo, S, Suraniti, F, Tavian, N, Tortelli, L, Tosoni, F, Valdagno, M, Zanobini, V, Barbui, C, and Haefeli, W

Subjects
QT interval, medicine.medical_specialty, electrocardiography, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Internal medicine, medicine, cohort study, 030212 general & internal medicine, drug–drug interaction, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Original Research, drug–drug interactions, psychiatry, medicine.diagnostic_test, business.industry, Pharmacodynamics, Cardiology, Psychology (miscellaneous), business, Electrocardiography, cohort study, drug–drug interactions, electrocardiography, psychiatry, QT interval, Cohort study
Abstract

Background:Whether arrhythmia risks will increase if drugs with electrocardiographic (ECG) QT-prolonging properties are combined is generally supposed but not well studied. Based on available evidence, the Arizona Center for Education and Research on Therapeutics (AZCERT) classification defines the risk of QT prolongation for exposure to single drugs. We aimed to investigate how combining AZCERT drug categories impacts QT duration and how relative drug exposure affects the extent of pharmacodynamic drug–drug interactions.Methods:In a cohort of 2558 psychiatric inpatients and outpatients, we modeled whether AZCERT class and number of coprescribed QT-prolonging drugs correlates with observed rate-corrected QT duration (QTc) while also considering age, sex, inpatient status, and other QTc-prolonging risk factors. We concurrently considered administered drug doses and pharmacokinetic interactions modulating drug clearance to calculate individual weights of relative exposure with AZCERT drugs. Because QTc duration is concentration-dependent, we estimated individual drug exposure with these drugs and included this information as weights in weighted regression analyses.Results:Drugs attributing a ‘known’ risk for clinical consequences were associated with the largest QTc prolongations. However, the presence of at least two versus one QTc-prolonging drug yielded nonsignificant prolongations [exposure-weighted parameter estimates with 95% confidence intervals for ‘known’ risk drugs + 0.93 ms (–8.88;10.75)]. Estimates for the ‘conditional’ risk class increased upon refinement with relative drug exposure and co-administration of a ‘known’ risk drug as a further risk factor.Conclusions:These observations indicate that indiscriminate combinations of QTc-prolonging drugs do not necessarily result in additive QTc prolongation and suggest that QT prolongation caused by drug combinations strongly depends on the nature of the combination partners and individual drug exposure. Concurrently, it stresses the value of the AZCERT classification also for the risk prediction of combination therapies with QT-prolonging drugs.

Published
2017

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