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1. 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

2. 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

3. 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

5. 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

6. 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

7. Genes involved in neuroplasticity and stressful life events act on the short-term response to antidepressant treatment: A complex interplay between genetics and environment

Author

Laura, Mandelli, Roberta, Emiliani, Stefano, Porcelli, Chiara, Fabbri, Diego, Albani, Alessandro, Serretti, Mandelli, L., Emiliani, R., Porcelli, S., Fabbri, C., Albani, D., and Serretti, A.

Subjects
Male, Heterozygote, Time Factors, Mood Disorder, Time Factor, Polymorphism, Single Nucleotide, Life Change Events, Haplotype, Humans, antidepressant, Mood Disorders, Brain-Derived Neurotrophic Factor, Sialyltransferase, Middle Aged, stressful life event, Anxiety Disorders, Antidepressive Agents, Sialyltransferases, BDNF, Treatment Outcome, Haplotypes, Antidepressive Agent, Female, Gene-Environment Interaction, Anxiety Disorder, ST8SIA2, Human
Abstract

During the last few years, an increasing number of studies have focused on the association between neuroplasticity and affective disorders. The aim of the study is to evaluate the interactive effect of stressful life events (SLEs) and genes involved in neuroplasticity (BDNF and ST8SIA) on the short-term response to antidepressant treatment.A total of 114 patients affected by mood or anxiety disorders under antidepressant treatment were enrolled in the study. We evaluated the interactive effects of three BDNF single-nucleotide polymorphisms (SNPs) and five ST8SIA SNPs and SLEs at different time points (childhood SLEs, SLEs at illness onset, and SLEs reported over the last preceding treatment) over 1-month of antidepressant treatment.Carriers of some genetic variants in both BDNF and ST8SIA had a slower response to antidepressants if non-exposed to the onset SLEs, whereas they had a similar trend compared with the carriers of the opposite variant if exposed (allelic analysis: BDNF p = 0.00003, p = 0.00609; ST8SIA p = 0.04, p = 0.033). The BDNF haplotype analysis confirmed this trend (p = 0.00016).Though our results are limited by the small sample size, variants in BDNF and ST8SIA may slow down the early response to antidepressants in subjects non-exposed to stressors at the illness onset, with a remarkable gene-environment interaction.

Published
2014

8. Identification of Novel Cryptic Chromosomal Abnormalities in Primary Myelofibrosis by Single-Nucleotide Polymorphism Oligonucleotide Microarray

Author

Alessandro Isidori, Stefania Paolini, Meris Donati, Elena Sabattini, Simona Righi, Claudia Mannu, Antonella Laginestra, Anna Gazzola, Nicola Vianelli, Claudio Agostinelli, Roberto Emiliani, Carlo Finelli, Michele De Nictolis, Massimo Valentini, Francesco Alesiani, Maura Rossi, Pier Paolo Piccaluga, Stefano Pileri, Stefano Ascani, Maria Rosaria Sapienza, Giovanni Martinelli, Giuseppe Visani, Ilaria Iacobucci, Visani G., Isidori A., Sapienza MR., Righi S., Laginestra A., Agostinelli C., Sabattini E., De Nictolis M., Valentini M., Donati M., Emiliani R., Gazzola A., Mannu C., Rossi M., Alesiani F., Martinelli G., Iacobucci I., Paolini S., Ascani S., Finelli C., Vianelli N., Pileri SA., and Piccaluga PP.

Subjects
Genetics, Immunology, Single-Nucleotide Polymorphism, Single-nucleotide polymorphism, Cell Biology, Hematology, Biology, medicine.disease, Biochemistry, Uniparental disomy, Loss of heterozygosity, Primary Myelofibrosi, Germline mutation, Chromosome abnormality, medicine, Copy-number variation, Genotyping, Oligonucleotide Microarray, SNP array
Abstract

Abstract 1890 Poster Board I-913 Background. Primary myelofibrosis (PMF) is a clonal myeloproliferative neoplasm (MPN) characterised by a proliferation of predominantly megakaryocytes and granulocytes in bone marrow that in fully developed disease is replaced by fibrous tissue. At molecular level, no specific defect has been identified yet. Cytogenetic abnormalities occur in up to 30% of patients, the commonest including del(13)(q12-22), der(6)t(1;6)(q21-23;p21.3), del (20q), and partial trisomy 1q. In addition, approximately 50% of patients with PMF exhibit a single, recurrent, somatic mutation in the gene encoding the cytoplasmic tyrosine kinase Janus kinase 2 (JAK2). However, such mutation is not specific, also occurring in other MPN. Recently a couple of reports dealt with single-nucleotide polymorphism (SNP) array karyotyping of MPD, including some PMF. Importantly, such studies could identify previously uncovered genetic lesions, highlighting the importance of novel high resolution technologies for the detection of formerly unknown, cryptic aberrations. In this study we performed high resolution karyotyping by SNP oligonucleotide microarray by using the most updated Affymetrix array (Genome-Wide Human SNP Array 6.0) in 20 cases of myelofibrosis (MF) in order to identify novel cryptic genomic aberrations. Methods. DNA (500 ng) was extracted from peripheral blood cells (PBMNC) of 14 primary and 6 secondary MF patients. PBMNC were depleted from lymphocytes by magnetic beads. Briefly, CD3+ cells were labeled with anti-CD3 MoAb directly coupled to magnetic microbeads (Miltenyi Biotech), washed and subsequently purified using Mini-MACS technology. After selection, cell present in the positive (CD3) and negative (PBMNC) fractions were counted and submitted to flow cytometry analysis. DNA was processed and hybridized to the Affymetrix SNP arrays 6.0 as for manufacturer instruction. A whole-genome copy number variation (CNV), genotyping, loss of heterozygosity (LOH) and uniparental disomy (UPD) analyses were performed using the Partek Suite 6.0. Ten lab-specific as well as 90 HapMap samples relative to Caucasian healthy donor were used as control reference. Genomic abnormalities were defined as recurrent when occurring in at least 25% of cases. JAK2 mutational status was assessed as reported, by alle-specific PCR. Clinical information and complete follow up were retrieved for all cases. Direct sequencing, FISH, qPCR and immunohistochemistry (IHC) has been chosen for validation. Results. In all patients we could detect several CNV. The median number of CNV was 60 (range, 34-72), including 46 amplifications (A) and 14 deletions (D). All commonest previously described abnormalities were detected. In addition, several formerly uncovered recurrent lesions were identified, mainly involving 1p, 1q, 2p, 4p, 4q, 5q, 6p, 6q, 7q, 8p, 9q 10q, 11p 11q, 12p, 14q, 15q, 16p, 16q, 17q, 18q, 19q, 20p, 22q. The median size of such CNV was 424,582 Kbp (1,379 Kbp-71,277 Mbp). We then compared JAK2+ vs. JAK2− cases. Of note, we found numerous definite aberrations (A or D) distinguishing the two groups and specifically affecting 16q23.1, 1p36.13, 3q26, 14q13.2, 5q33.2, 6q14.1, 7q33, 8p23.1, and 9p11.2. Grippingly, several genes of potential interest for PMF pathogenesis were identified within the involved loci, including RET, SCAPER, WWOX and SIRPB1. Among others, the product of such genes has been selected for validation by IHC. Similarly, many miRNA were recognized, which may deserve further investigation. Conclusions. By using a newly developed highly sensitive array we identified novel cryptic lesions in patients affected by MF. Future studies on larger series, as well as functional analyses will definitely assess their role in the pathogenesis of the disease. Of note, consistent differences were recorded in JAK2+ vs. JAK2−, supporting the hypothesis of different genetic mechanisms occurring in the two sub-groups. Acknowledgments: this work was supported by AIL Pesaro Onlus, Centro Interdipartimentale per la Ricerca sul Cancro “G. Prodi”, BolognAIL, AIRC, FIRB, RFO, Fondazione Cassa di Risparmio in Bologna, Fondazione della Banca del Monte e Ravenna, Progetto Strategico di Ateneo 2006.*GV and MRS equally contributed to this work. Disclosures: No relevant conflicts of interest to declare.

Published
2009

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