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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.
Trials. 2009 May 15; 10:31.T

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.

Authors+Show Affiliations

Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Italy. michela.nose@univr.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19445659

Citation

Nosè, Michela, et al. "Rationale and Design of an Independent Randomised Controlled Trial Evaluating the Effectiveness of Aripiprazole or Haloperidol in Combination With Clozapine for Treatment-resistant Schizophrenia." Trials, vol. 10, 2009, p. 31.
Nosè M, Accordini S, Artioli P, et al. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia. Trials. 2009;10:31.
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., ... Ziero, S. (2009). Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia. Trials, 10, 31. https://doi.org/10.1186/1745-6215-10-31
Nosè M, et al. Rationale and Design of an Independent Randomised Controlled Trial Evaluating the Effectiveness of Aripiprazole or Haloperidol in Combination With Clozapine for Treatment-resistant Schizophrenia. Trials. 2009 May 15;10:31. PubMed PMID: 19445659.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia. AU - Nosè,Michela, AU - Accordini,Simone, AU - Artioli,Paola, AU - Barale,Francesco, AU - Barbui,Corrado, AU - Beneduce,Rossella, AU - Berardi,Domenico, AU - Bertolazzi,Gerardo, AU - Biancosino,Bruno, AU - Bisogno,Alfredo, AU - Bivi,Raffaella, AU - Bogetto,Filippo, AU - Boso,Marianna, AU - Bozzani,Alberto, AU - Bucolo,Piera, AU - Casale,Marcello, AU - Cascone,Liliana, AU - Ciammella,Luisa, AU - Cicolini,Alessia, AU - Cipresso,Gabriele, AU - Cipriani,Andrea, AU - Colombo,Paola, AU - Dal Santo,Barbara, AU - De Francesco,Michele, AU - Di Lorenzo,Giorgio, AU - Di Munzio,Walter, AU - Ducci,Giuseppe, AU - Erlicher,Arcadio, AU - Esposito,Eleonora, AU - Ferrannini,Luigi, AU - Ferrato,Farida, AU - Ferro,Antonio, AU - Fragomeno,Nicoletta, AU - Parise,Vincenzo Fricchione, AU - Frova,Maria, AU - Gardellin,Francesco, AU - Garzotto,Nicola, AU - Giambartolomei,Andrea, AU - Giupponi,Giancarlo, AU - Grassi,Luigi, AU - Grazian,Natalia, AU - Grecu,Lorella, AU - Guerrini,Gualtiero, AU - Laddomada,Francesco, AU - Lazzarin,Ermanna, AU - Lintas,Camilla, AU - Malchiodi,Francesca, AU - Malvini,Lara, AU - Marchiaro,Livio, AU - Marsilio,Alessandra, AU - Mauri,Massimo Carlo, AU - Mautone,Antonio, AU - Menchetti,Marco, AU - Migliorini,Giuseppe, AU - Mollica,Marco, AU - Moretti,Daniele, AU - Mulè,Serena, AU - Nicholau,Stylianos, AU - Nosè,Flavio, AU - Occhionero,Guglielmo, AU - Pacilli,Anna Maria, AU - Pecchioli,Stefania, AU - Percudani,Mauro, AU - Piantato,Ennio, AU - Piazza,Carlo, AU - Pontarollo,Francesco, AU - Pycha,Roger, AU - Quartesan,Roberto, AU - Rillosi,Luciana, AU - Risso,Francesco, AU - Rizzo,Raffella, AU - Rocca,Paola, AU - Roma,Stefania, AU - Rossattini,Matteo, AU - Rossi,Giuseppe, AU - Rossi,Giovanni, AU - Sala,Alessandra, AU - Santilli,Claudio, AU - Saraò,Giuseppe, AU - Sarnicola,Antonio, AU - Sartore,Francesca, AU - Scarone,Silvio, AU - Sciarma,Tiziana, AU - Siracusano,Alberto, AU - Strizzolo,Stefania, AU - Tansella,Michele, AU - Targa,Gino, AU - Tasser,Annamarie, AU - Tomasi,Rodolfo, AU - Travaglini,Rossana, AU - Veronese,Antonio, AU - Ziero,Simona, Y1 - 2009/05/15/ PY - 2009/02/06/received PY - 2009/05/15/accepted PY - 2009/5/19/entrez PY - 2009/5/19/pubmed PY - 2009/7/10/medline SP - 31 EP - 31 JF - Trials JO - Trials VL - 10 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/19445659/Rationale_and_design_of_an_independent_randomised_controlled_trial_evaluating_the_effectiveness_of_aripiprazole_or_haloperidol_in_combination_with_clozapine_for_treatment_resistant_schizophrenia_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-10-31 DB - PRIME DP - Unbound Medicine ER -