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1. 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. …] more...

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. more...

Published
2011

2. 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

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

Subjects
Medicine (General), R5-920
Abstract

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 more...

Published
2009
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3. 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. more...

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 more...

Published
2009