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

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Author(s): 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 | 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 | Mautone Antonio | Menchetti Marco | Migliorini Giuseppe | Mollica Marco | Moretti Daniele | Mulè Serena | Nicholau Stylianos | Nosè Flavio | Occhionero Guglielmo | Pacilli Anna | 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

Journal: Trials
ISSN 1745-6215

Volume: 10;
Issue: 1;
Start page: 31;
Date: 2009;
Original page

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

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