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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. …]

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

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

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

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.

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

4. [Heterogeneity of the Departments of Mental Health in the Veneto Region ten years after the National Plan 1994-96 for Mental Health. Which implication for clinical practice? Findings from the PICOS Project].

Author

Lasalvia A, Gentile B, Ruggeri M, Marcolin A, Nosè F, Cappellari L, Lamonaca D, Toniolo E, Busana C, Campedelli A, Cuccato G, Danieli A, De Nardi F, De Nardo V, Destro E, Favaretto G, Frazzingaro S, Giacopuzzi M, Pristinger P, Pullia G, Rodighiero S, Tito P, Aprile F, Nicolaou S, Coppola G, Garzotto N, Gottardi U, Lazzarin E, Migliorini G, Pavan L, Ramaciotti F, Roveroni P, Russo S, Urbani P, and Tansella M

Subjects
Catchment Area, Health, Community Mental Health Services supply & distribution, Day Care, Medical legislation & jurisprudence, Hospitals, Psychiatric legislation & jurisprudence, Hospitals, Psychiatric supply & distribution, Humans, Italy epidemiology, National Health Programs, Public Health Administration, Small-Area Analysis, Community Mental Health Services legislation & jurisprudence, Community Mental Health Services statistics & numerical data, Day Care, Medical statistics & numerical data, Health Policy, Hospitals, Psychiatric statistics & numerical data, Interprofessional Relations, Mental Disorders epidemiology, Mental Disorders therapy, Professional Practice Location statistics & numerical data
Abstract

Aims: This study aims to present data on structural and human resources of public mental health services located in the Veneto Region, Italy, and to discuss them in the light of implementation of the first National Target Plan for Mental Health ("Progetto Obiettivo 1994-1996") ten years after its launch., Methods: The study was conducted in the context of the PICOS (Psychosis Incident Cohort Outcome Study) Project, a large first-presentation multisite study on patients with psychotic disorders attending community mental heath services in the Veneto Region. Human and structural resources were surveyed in 26 study sites using a structured interview administered by the PICOS local referents., Results: CMHCs and Day Centres were homogeneously distributed across the Region and their overall rates per resident population met the national standards; a wide variability in the distribution of Day Hospitals was found, with the overall rate per resident population very far from meeting the national standard; the overall rate for Residential Facilities beds was higher than the recommended national standard, showing however an high variability across sites. The overall rate of mental health professionals per resident population was only slightly below the national standard: this was mainly achieved thanks to non-profit organizations which supplement the public system with unspecialised professionals; however, a wide variability in the local rates per resident population was found, with the 50% of the sites showing rates far lower the national standard. Specific lack of trained professionals involved in the provision of psychosocial interventions was found in most sites., Conclusions: A marked variability in human and structural resources across community mental health services in the Veneto Region was found. Possible reasons for this heterogeneity were analysed and implications for mental health care provision were further discussed.

Published
2007

5. [Not Available].

Author

Bonuzzi L and Nosè F

Subjects
France, History, Modern 1601-, Hospitals history
Published
1975

6. [XYY syndrome and behavior disorders].

Author

Guaraldi GP and Nosè F

Subjects
Adolescent, Adult, Humans, Aggression genetics, Criminal Psychology, Mental Disorders genetics, Sex Chromosome Aberrations complications, Trisomy
Published
1970

7. [Not Available].

Author

Bonuzzi L and Nosè F

Subjects
Germany, History, Early Modern 1451-1600, History, Modern 1601-, Art history, Mental Disorders history
Published
1970

8. [Not Available].

Author

Bonuzzi L, Carletti G, Ciccarelli G, and Nosè F

Subjects
History, Modern 1601-, Italy, Hospitals, Psychiatric history, Military Medicine history
Published
1974

9. [Not Available].

Author

Zuanazzi G and Nosè F

Subjects
History, Ancient, History, Early Modern 1451-1600, History, Medieval, History, Modern 1601-, Psychology history, Religion and Medicine, Symbolism
Published
1971

10. [Initial results of clinical trial of a new long-acting neuroleptic agent: Fluspirelene].

Author

Ciccarelli G and Nosè F

Subjects
Adolescent, Adult, Evaluation Studies as Topic, Female, Humans, Hydrocarbons, Halogenated therapeutic use, Male, Middle Aged, Piperidines therapeutic use, Time Factors, Neurotic Disorders drug therapy, Paranoid Disorders drug therapy, Schizophrenia drug therapy, Spiro Compounds therapeutic use, Tranquilizing Agents therapeutic use
Published
1971

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