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

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...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 10; no. 1; p. 31
Main Authors:	Nosè, Michela, Accordini, Simone, Artioli, Paola, Barale, Francesco, Barbui, Corrado, Beneduce, Rossella, Berardi, Domenico, Bertolazzi, Gerardo, Biancosino, Bruno, Bisogno, Alfredo, Bivi, Raffaella, Bogetto, Filippo, Boso, Marianna, Bozzani, Alberto, Bucolo, Piera, Casale, Marcello, Cascone, Liliana, Ciammella, Luisa, Cicolini, Alessia, Cipresso, Gabriele, Cipriani, Andrea, Colombo, Paola, Dal Santo, Barbara, De Francesco, Michele, Di Lorenzo, Giorgio, Di Munzio, Walter, Ducci, Giuseppe, Erlicher, Arcadio, Esposito, Eleonora, Ferrannini, Luigi, Ferrato, Farida, Ferro, Antonio, Fragomeno, Nicoletta, Parise, Vincenzo Fricchione, Frova, Maria, Gardellin, Francesco, Garzotto, Nicola, Giambartolomei, Andrea, Giupponi, Giancarlo, Grassi, Luigi, Grazian, Natalia, Grecu, Lorella, Guerrini, Gualtiero, Laddomada, Francesco, Lazzarin, Ermanna, Lintas, Camilla, Malchiodi, Francesca, Malvini, Lara, Marchiaro, Livio, Marsilio, Alessandra, Mauri, Massimo Carlo, Mautone, Antonio, Menchetti, Marco, Migliorini, Giuseppe, Mollica, Marco, Moretti, Daniele, Mulè, Serena, Nicholau, Stylianos, Nosè, Flavio, Occhionero, Guglielmo, Pacilli, Anna Maria, Pecchioli, Stefania, Percudani, Mauro, Piantato, Ennio, 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, Ziero, Simona
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 15-05-2009 BioMed Central BMC
Subjects:	Antipsychotic Agents - therapeutic use Antipsychotic drugs Antipsychotics Aripiprazole Clinical Protocols Clinical trials Clozapine Clozapine - therapeutic use Drug Resistance Drug therapy Drug Therapy, Combination Government Regulation Haloperidol Haloperidol - therapeutic use Health aspects Humans Intervention Italy Legislation Mental disorders Mental health Patient outcomes Pharmaceutical industry Piperazines - therapeutic use Prescription drugs Prospective Studies Psychosis Psychotropic drugs Quinolones - therapeutic use Research Design - legislation & jurisprudence Schizophrenia Schizophrenia - drug therapy Schizophrenic Psychology Study Protocol Treatment Outcome Italy
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Summary:	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. 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. 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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	1745-6215 1745-6215
DOI:	10.1186/1745-6215-10-31