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7 results on '"Gardellin, F"'

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

4. Prevalence and correlates of QTc prolongation in Italian psychiatric care: cross-sectional multicentre study

Author

Nosè, M., Bighelli, I., Castellazzi, M., Martinotti, G., Carrà, G., Lucii, C., Ostuzzi, G., Sozzi, F., Barbui, C., 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., 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., 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., 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., Santoro, R., Santi, M., Signorelli, M. S., Soscia, F., Staffa, P., Stilo, M., Strizzolo, S., Suraniti, F., Tavian, N., Tortelli, L., Tosoni, F., Valdagno, M., Zanobini, V., Nosè, M, Bighelli, I, Castellazzi, M, Martinotti, G, Carra', G, Lucii, C, Ostuzzi, G, Sozzi, F, Barbui, C, 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, 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, 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, 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, Santoro, R, Santi, M, Signorelli, M, Soscia, F, Staffa, P, Stilo, M, Strizzolo, S, Suraniti, F, Tavian, N, Tortelli, L, Tosoni, F, Valdagno, M, and Zanobini, V

Subjects
Adult, Male, medicine.medical_specialty, Psychotropic drugs, Epidemiology, medicine.medical_treatment, Long QT syndrome, Antidepressant, Drug overdose, Adverse effect, QT interval, Antipsychotic, 03 medical and health sciences, Electrocardiography, 0302 clinical medicine, Risk Factors, Psychotropic drug, medicine, Prevalence, Humans, cardiovascular diseases, Psychiatry, Settore MED/25 - Psichiatria, Polypharmacy, business.industry, Environmental and Occupational Health, Public Health, Environmental and Occupational Health, Public Health, Psychiatry and Mental Health, Original Articles, medicine.disease, 030227 psychiatry, Substance abuse, Long QT Syndrome, Cross-Sectional Studies, Italy, Aripiprazole, Female, business, adverse effect, antipsychotic, psychotropic drugs, Antipsychotic Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract

Aims.In recent years several warnings have been issued by regulatory authorities on the risk of electrocardiogram abnormalities in individuals exposed to psychotropic drugs. As a consequence of these warnings, monitoring of the QT interval corrected for heart rate (QTc) has become increasingly common. This study was conducted to measure the frequency of QTc prolongation in unselected psychiatric patients, and to document the associated factors using a cross-sectional approach.Method.The study was carried out in 35 Italian psychiatric services that are part of the STAR (Servizi Territoriali Associati per la Ricerca) Network, a research group established to produce scientific knowledge by collecting data under ordinary circumstances. During a three-month period, a consecutive unselected series of both in- and out-patients were enrolled if they performed an ECG during the recruitment period and were receiving psychotropic drugs on the day ECG was recorded.Results.During the recruitment period a total of 2411 patients were included in the study. The prevalence of QTc prolongation ranged from 14.7% (men) and 18.6% (women) for the cut-off of 450 ms, to 1.26% (men) and 1.01% (women) for the cut-off of 500 ms. In the multivariate model conducted in the whole sample of patients exposed to psychotropic drugs, female sex, age, heart rate, alcohol and/or substance abuse, cardiovascular diseases and cardiovascular drug treatment, and drug overdose were significantly associated with QTc prolongation. In patients exposed to antipsychotic drugs, polypharmacy was positively associated with QTc prolongation, whereas use of aripiprazole decreased the risk. In patients exposed to antidepressant drugs, use of citalopram, citalopram dose and use of haloperidol in addition to antidepressant drugs, were all positively associated with QTc prolongation.Conclusions.The confirmation of a link between antipsychotic polypharmacy and QTc prolongation supports the current guidelines that recommend avoiding the concurrent use of two or more antipsychotic drugs, and the confirmation of a link between citalopram and QTc prolongation supports the need for routine QTc monitoring. The relatively low proportion of patients with QTc prolongation not only suggests compliance with current safety warnings issued by regulatory authorities, but also casts some doubts on the clinical relevance of QTc prolongation related to some psychotropic drugs.

Published
2016

5. 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

6. Aripiprazole Versus Haloperidol in Combination With Clozapine for Treatment-Resistant Schizophrenia in Routine Clinical Care A Randomized, Controlled Trial

Author

Barbui, C, Accordini, S, Nosè, M, Stroup, S, Purgato, M, Girlanda, F, Esposito, E, Veronese, A, Tansella, M, Cipriani, A, CHAT Clozapine Haloperidol Aripiprazole Trial, Study Group, Losavio, T, Percudani, M, Aldini, F, Appino, Mg, Artioli, P, Barale, F, Beneduce, R, Berardi, D, Bertolazzi, G, Biancosino, B, Bisogno, A, Bivi, R, Bogetto, F, Boso, M, Bozzani, A, Bucolo, P, Casale, M, Cascone, L, Ciammella, L, Cicolini, A, Cipresso, G, Colombo, P, Dal Santo, B, De Francesco, M, Di Lorenzo, G, Di Munzio, W, Erlicher, A, Ferrannini, L, Ferrato, F, Ferro, A, Fragomeno, N, Fricchione Parise, V, Frova, M, Gardellin, F, Garzotto, N, Giambartolomei, A, Giupponi, G, Grassi, L, Grazian, N, Grecu, L, Guerrini, G, Laddomada, F, Lazzarin, E, Lintas, C, Malchiodi, F, Malvini, L, Marchiaro, L, Marsilio, A, Mauri, Mc, Mautone, A, Menchetti, M, Migliorini, G, Mollica, M, Moretti, D, Mulè, S, Nicholau, S, Nosè, F, Occhionero, G, Pacilli, Am, Pecchioli, S, Petrosemolo, P, Piantato, E, Piazza, C, Pontarollo, F, Pycha, R, Quartesan, Roberto, Rillosi, L, Risso, F, Rizzo, R, Rocca, P, Roma, S, Rossattini, M, Rossi, G, Sala, A, Santilli, C, Saraò, G, Sarnicola, A, Sartore, F, Scarone, S, Sciarma, Tiziana, Siracusano, A, Strizzolo, S, Targa, G, Tasser, A, Tomasi, R, Travaglini, R, Valentini, C, Ziero, S., Barbui C., Accordini S., Nosè M., Stroup S., Purgato M., Girlanda F., Esposito E., Veronese A., Tansella M., Cipriani A., CHAT (Clozapine Haloperidol Aripiprazole Trial) Study Group […, Losavio T., Percudani M., Aldini F., Appino M.G., Artioli P., Barale F., Beneduce R., Berardi D., Bertolazzi G., Biancosino B., Bisogno A., Bivi R., Bogetto F., Boso M., Bozzani A., Bucolo P., Casale M., Cascone L., Ciammella L., Cicolini A., Cipresso G., Colombo P., Dal Santo B., De Francesco M., Di Lorenzo G., Di Munzio W., Erlicher A., Ferrannini L., Ferrato F., Ferro A., Fragomeno N., Fricchione Parise V., Frova M., Gardellin F., Garzotto N., Giambartolomei A., Giupponi G., Grassi L., Grazian N., Grecu L., Guerrini G., Laddomada F., Lazzarin E., Lintas C., Malchiodi F., Malvini L., Marchiaro L., Marsilio A., Mauri M.C., Mautone A., Menchetti M., Migliorini G., Mollica M., Moretti D., Mulè S., Nicholau S., Nosè F., Occhionero G., Pacilli A.M., Pecchioli S., Petrosemolo P., Piantato E., Piazza C., Pontarollo F., Pycha R., Quartesan R., Rillosi L., Risso F., Rizzo R., Rocca P., Roma S., Rossattini M., Rossi G., Sala A., Santilli C., Saraò G., Sarnicola A., Sartore F., Scarone S., Sciarma T., Siracusano A., Strizzolo S., Targa G., Tasser A., Tomasi R., Travaglini R., Valentini C., and Ziero S. …]

Subjects
Adult, Male, medicine.medical_specialty, antipsychotics, aripiprazole, clozapine, combination strategies, schizophrenia, medicine.drug_class, medicine.medical_treatment, Drug Resistance, Atypical antipsychotic, Quinolones, Piperazines, law.invention, Randomized controlled trial, law, Internal medicine, Brief Psychiatric Rating Scale, medicine, Haloperidol, Humans, Pharmacology (medical), humans, quinolones, drug resistance, brief psychiatric rating scale, antipsychotic agents, drug therapy, combination, haloperidol, piperazines, adult, female, male, Psychiatry, Antipsychotic, Settore MED/25 - Psichiatria, Clozapine, combination, Randomised Controlled Trial, Aripiprazole, ATYPICAL ANTIPSYCHOTICS, TREATMENT RESISTANCE, drug therapy, Psychiatry and Mental health, Tolerability, Treatment-resistant, Schizophrenia, Drug Therapy, Combination, Female, Psychology, Antipsychotic Agents, medicine.drug
Abstract

This multisite study was conducted to compare the efficacy and tolerability of combination treatment with clozapine plus aripiprazole versus combination treatment with clozapine plus haloperidol in patients with schizophrenia who do not have an optimal response to clozapine. Patients continued to take clozapine and were randomly assigned to receive daily augmentation with aripiprazole or haloperidol. Physicians prescribed the allocated treatments according to usual clinical care. Withdrawal from allocated treatment within 3 months was the primary outcome. Secondary outcomes included severity of symptoms on the Brief Psychiatric Rating Scale and antipsychotic subjective tolerability on the Liverpool University Neuroleptic Side Effect Rating Scale. A total of 106 patients with schizophrenia were randomly assigned to treatment. After 3 months, we found no difference in the proportion of patients who discontinued treatment between the aripiprazole and haloperidol groups (13.2% vs 15.1%, P = 0.780). The 3-month change of the Brief Psychiatric Rating Scale total score was similar in the aripiprazole and haloperidol groups (-5.9 vs -4.4 points, P = 0.523), whereas the 3-month decrease of the Liverpool University Neuroleptic Side Effect Rating Scale total score was significantly higher in the aripiprazole group than in the haloperidol group (-7.4 vs -2.0 points, P = 0.006). These results suggest that augmentation of clozapine with aripiprazole offers no benefit with regard to treatment withdrawal and overall symptoms in schizophrenia compared with augmentation with haloperidol. However, an advantage in the perception of adverse effects with aripiprazole treatment may be meaningful for patients.

Published
2011

7. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

Author

Paola Colombo, Luisa Ciammella, Giancarlo Giupponi, Francesco Barale, Luigi Grassi, Giorgio Di Lorenzo, Maria Frova, Michela Nosè, Gualtiero Guerrini, Liliana Cascone, Francesco Pontarollo, Rodolfo Tomasi, Alfredo Bisogno, Francesca Sartore, Guglielmo Occhionero, Claudio Santilli, Andrea Giambartolomei, Tiziana Sciarma, Marco Menchetti, Matteo Rossattini, Giuseppe Saraò, Farida Ferrato, Gabriele Cipresso, Alessandra Marsilio, Simone Accordini, Anna Maria Pacilli, Francesco Laddomada, Marianna Boso, Giuseppe Migliorini, Lara Malvini, Camilla Lintas, Antonio Ferro, Alessia Cicolini, Luciana Rillosi, Annamarie Tasser, Alberto Siracusano, Mauro Percudani, Roberto Quartesan, Nicoletta Fragomeno, Nicola Garzotto, Flavio Nosè, Corrado Barbui, Raffaella Bivi, Antonio Mautone, Rossella Beneduce, Gerardo Bertolazzi, Andrea Cipriani, Eleonora Esposito, Alberto Bozzani, Stylianos Nicholau, Barbara Dal Santo, Antonio Veronese, Gino Targa, Rossana Travaglini, Ermanna Lazzarin, Francesco Gardellin, Luigi Ferrannini, Stefania Roma, Giuseppe Rossi, Giovanni Rossi, Alessandra Sala, Bruno Biancosino, Massimo Carlo Mauri, Simona Ziero, Domenico Berardi, Roger Pycha, Walter Di Munzio, Serena Mulè, Michele De Francesco, Filippo Bogetto, Arcadio Erlicher, Carlo Piazza, Francesco Risso, Stefania Strizzolo, Marcello Casale, Vincenzo Fricchione Parise, Lorella Grecu, Silvio Scarone, Paola Artioli, Giuseppe Ducci, Raffella Rizzo, Michele Tansella, Natalia Grazian, Livio Marchiaro, Daniele Moretti, Marco Mollica, Paola Rocca, Piera Bucolo, Antonio Sarnicola, Stefania Pecchioli, Ennio Piantato, Francesca Malchiodi, Nosè M, Accordini S, Artioli P, Barale F, Barbui C, Beneduce R, Berardi D, Bertolazzi G, Biancosino B, Bisogno A, Bivi R, Bogetto F, Boso M, Bozzani A, Bucolo P, Casale M, Cascone L, Ciammella L, Cicolini A, Cipresso G, Cipriani A, Colombo P, Dal Santo B, De Francesco M, Di Lorenzo G, Di Munzio W, Ducci G, Erlicher A, Esposito E, Ferrannini L, Ferrato F, Ferro A, Fragomeno N, Parise VF, Frova M, Gardellin F, Garzotto N, Giambartolomei A, Giupponi G, Grassi L, Grazian N, Grecu L, Guerrini G, Laddomada F, Lazzarin E, Lintas C, Malchiodi F, Malvini L, Marchiaro L, Marsilio A, Mauri MC, Mautone A, Menchetti M, Migliorini G, Mollica M, Moretti D, Mulè S, Nicholau S, Nosè F, Occhionero G, Pacilli AM, Pecchioli S, Percudani M, Piantato E, Piazza C, Pontarollo F, Pycha R, Quartesan R, Rillosi L, Risso F, Rizzo R, Rocca P, Roma S, Rossattini M, Rossi G, Sala A, Santilli C, Saraò G, Sarnicola A, Sartore F, Scarone S, Sciarma T, Siracusano A, Strizzolo S, Tansella M, Targa G, Tasser A, Tomasi R, Travaglini R, Veronese A, and Ziero S.

Subjects
REFRACTORY SCHIZOPHRENIA, Schizophrenia, treatment-resistance, antipsychotics, medicine.medical_treatment, Aripiprazole, piperazines, Medicine (miscellaneous), Antipsychotic Agents, Clinical Protocols, Clozapine, Drug Therapy, Combination, Government Regulation, Haloperidol, Humans, Italy, Piperazines, Prospective Studies, Quinolones, Research Design, Treatment Outcome, Drug Resistance, Schizophrenic Psychology, law.invention, haloperidol, Study Protocol, DOUBLE-BLIND, Randomized controlled trial, law, Pharmacology (medical), schizophrenic psychology, humans, antipsychotic agents, clinical protocols, clozapine, drug resistance, drug therapy, combination, government regulation, haloperidol, humans, Italy, piperazines, prospective studies, quinolones, research design, schizophrenia, schizophrenic psychology, treatment outcome, lcsh:R5-920, treatment-resistant schizophrenia, aripiprazole, clozapine, ANTIPSYCHOTIC DRUGS, PRAGMATIC TRIALS, CLINICAL TRIALS, AUGMENTATION, METAANALYSIS, government regulation, antipsychotic agents, research design, drug therapy, lcsh:Medicine (General), medicine.drug, medicine.medical_specialty, Context (language use), medicine, clinical protocols, Antipsychotic, Psychiatry, Settore MED/25 - Psichiatria, Polypharmacy, combination, drug resistance, business.industry, medicine.disease, prospective studies, Clinical trial, schizophrenia, treatment outcome, quinolones, business
Abstract

Background One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. Methods/Design The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. Discussion The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia. Trial Registration Clincaltrials.gov Identifier: NCT00395915

Published
2009

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