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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- 作者：Michela Nosè (1)
Simone Accordini (2)
Paola Artioli (4)
Francesco Barale (5)
Corrado Barbui (1)
Rossella Beneduce (6)
Domenico Berardi (7)
Gerardo Bertolazzi (8)
Bruno Biancosino (9)
Alfredo Bisogno (10)
Raffaella Bivi (9)
Filippo Bogetto (11)
Marianna Boso (5)
Alberto Bozzani (12)
Piera Bucolo (13)
Marcello Casale (14)
Liliana Cascone (10)
Luisa Ciammella (15)
Alessia Cicolini (1)
Gabriele Cipresso (15)
Andrea Cipriani (1)
Paola Colombo (16)
Barbara Dal Santo (4)
Michele De Francesco (17)
Giorgio Di Lorenzo (18)
Walter Di Munzio (10)
Giuseppe Ducci (19)
Arcadio Erlicher (20)
Eleonora Esposito (1)
Luigi Ferrannini (3)
Farida Ferrato (21)
Antonio Ferro (22)
Nicoletta Fragomeno (23)
Vincenzo Fricchione Parise (24)
Maria Frova (20)
Francesco Gardellin (25)
Nicola Garzotto (26)
Andrea Giambartolomei (19)
Giancarlo Giupponi (17)
Luigi Grassi (9)
Natalia Grazian (20)
Lorella Grecu (23)
Gualtiero Guerrini (27)
Francesco Laddomada (12)
Ermanna Lazzarin (25)
Camilla Lintas (26)
Francesca Malchiodi (28)
Lara Malvini (21)
Livio Marchiaro (29)
Alessandra Marsilio (30)
Massimo Carlo Mauri (31)
Antonio Mautone (14)
Marco Menchetti (7)
Giuseppe Migliorini (32)
Marco Mollica (3)
Daniele Moretti (22)
Serena Mulè (1)
Stylianos Nicholau (8)
Flavio Nosè (33)
Guglielmo Occhionero (13)
Anna Maria Pacilli (29)
Stefania Pecchioli (23)
Mauro Percudani (16)
Ennio Piantato (34)
Carlo Piazza (32)
Francesco Pontarollo (1)
Roger Pycha (35)
Roberto Quartesan (36)
Luciana Rillosi (6)
Francesco Risso (29)
Raffella Rizzo (33)
Paola Rocca (11)
Stefania Roma (19)
Matteo Rossattini (31)
Giuseppe Rossi (6)
Giovanni Rossi (30)
Alessandra Sala (25)
Claudio Santilli (36)
Giuseppe Saraò (23)
Antonio Sarnicola (19)
Francesca Sartore (34)
Silvio Scarone (4)
Tiziana Sciarma (36)
Alberto Siracusano (18)
Stefania Strizzolo (25)
Michele Tansella (1)
Gino Targa (9)
Annamarie Tasser (35)
Rodolfo Tomasi (17)
Rossana Travaglini (23)
Antonio Veronese (1)
Simona Ziero (13) - 刊名：Trials
- 出版年：2009
- 出版时间：December 2009
- 年：2009
- 卷：10
- 期：1
- 全文大小：693KB
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Simone Accordini (2)
Paola Artioli (4)
Francesco Barale (5)
Corrado Barbui (1)
Rossella Beneduce (6)
Domenico Berardi (7)
Gerardo Bertolazzi (8)
Bruno Biancosino (9)
Alfredo Bisogno (10)
Raffaella Bivi (9)
Filippo Bogetto (11)
Marianna Boso (5)
Alberto Bozzani (12)
Piera Bucolo (13)
Marcello Casale (14)
Liliana Cascone (10)
Luisa Ciammella (15)
Alessia Cicolini (1)
Gabriele Cipresso (15)
Andrea Cipriani (1)
Paola Colombo (16)
Barbara Dal Santo (4)
Michele De Francesco (17)
Giorgio Di Lorenzo (18)
Walter Di Munzio (10)
Giuseppe Ducci (19)
Arcadio Erlicher (20)
Eleonora Esposito (1)
Luigi Ferrannini (3)
Farida Ferrato (21)
Antonio Ferro (22)
Nicoletta Fragomeno (23)
Vincenzo Fricchione Parise (24)
Maria Frova (20)
Francesco Gardellin (25)
Nicola Garzotto (26)
Andrea Giambartolomei (19)
Giancarlo Giupponi (17)
Luigi Grassi (9)
Natalia Grazian (20)
Lorella Grecu (23)
Gualtiero Guerrini (27)
Francesco Laddomada (12)
Ermanna Lazzarin (25)
Camilla Lintas (26)
Francesca Malchiodi (28)
Lara Malvini (21)
Livio Marchiaro (29)
Alessandra Marsilio (30)
Massimo Carlo Mauri (31)
Antonio Mautone (14)
Marco Menchetti (7)
Giuseppe Migliorini (32)
Marco Mollica (3)
Daniele Moretti (22)
Serena Mulè (1)
Stylianos Nicholau (8)
Flavio Nosè (33)
Guglielmo Occhionero (13)
Anna Maria Pacilli (29)
Stefania Pecchioli (23)
Mauro Percudani (16)
Ennio Piantato (34)
Carlo Piazza (32)
Francesco Pontarollo (1)
Roger Pycha (35)
Roberto Quartesan (36)
Luciana Rillosi (6)
Francesco Risso (29)
Raffella Rizzo (33)
Paola Rocca (11)
Stefania Roma (19)
Matteo Rossattini (31)
Giuseppe Rossi (6)
Giovanni Rossi (30)
Alessandra Sala (25)
Claudio Santilli (36)
Giuseppe Saraò (23)
Antonio Sarnicola (19)
Francesca Sartore (34)
Silvio Scarone (4)
Tiziana Sciarma (36)
Alberto Siracusano (18)
Stefania Strizzolo (25)
Michele Tansella (1)
Gino Targa (9)
Annamarie Tasser (35)
Rodolfo Tomasi (17)
Rossana Travaglini (23)
Antonio Veronese (1)
Simona Ziero (13)
1. Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Italy
2. Unit of Epidemiology and Medical Statistics,Department of Medicine and Public Health University of Verona, Italy
4. UOP 51 Psichiatria A.O. San Paolo, Milano, Italy
5. Department of Applied Health and Behavioral Sciences, Section of Psychiatry, University of Pavia, Italy
6. Centro S. Giovanni di Dio IRCCS FBF, Brescia, Italy
7. Institute of Psychiatry, Bologna University, Italy
8. Dipartimento Salute Mentale- Servizio Psichiatrico Area sud-ULSS 22, VeronaItaly
9. Department of Medical Sciences of Communication and Behaviour, Section of Psychiatry,University of Ferrara and Department of Mental Health, Ferrara, Italy
10. DSM ASL Salerno 1, Salerno, Italy
11. Dipartimento di Neuroscienze, Universita' degli Studi di Torino, Italy
12. Dipartimento Salute Mentale, ASL Taranto, Italy
13. DSM, ASL 19, Asti, Italy
14. Unità Operativa Salute Mentale,distretto 112/113, ASL Salerno 3, Salerno, Italy
15. Dipartimento di Salute Mentale, ASL n. 3 " Genovese", Genova, Italy
16. Psychiatric Unit of Bollate, Department of Mental Health, Hospital "G. Salvini",Garbagnate Milanese, Milano, Italy
17. Azienda Sanitaria di Bolzano, CSM, Italy
18. UnitE Operativa Complessa di Psichiatria,Dipartimento di Neuroscienze, Facoltà di Medicina e Chirurgia, Università degli Studi di Roma "Tor Vergata", Roma, Italy
19. Ospedale San Filippo Neri, ASL RM E, Roma, UOC, SPDC, Italy
20. Azienda Ospedaliera "Ospedale Niguarda Ca' Granda", Milano, Italy
3. Dipartimento di Salute Mentale, ASL n. 3 " Genovese", Genova, Italy
21. Unità Operativa n42, Rho, Azienda Ospedaliera "G. Salvini",Garbagnate Milanese, Milano, Italy
22. ASL n2 "Savonese", Savona, DSM, Italy
23. ASF-Toscana (Centro Salute Mentale del MOM-SMA Q2), Firenze, Italy
24. U.O.Salute Mentale "Roseto", ASL AV2, Avellino, Italy
25. Centro di Salute Mentale di Vicenza (ULSS 6), Vicenza, Italy
26. First Psychiatric Service,Ospedale Civile Maggiore, ULSS 20, Verona, Italy
27. Centro Salute mentale ASL 5, La Spezia, Italy
28. Melegnano,sede Gorgonzola, Servizio Psichiatrico, AO, Italy
29. Struttura Complessa di Psichiatria, A.S.L. CN1, Cuneo, Italy
30. Azienda Ospedaliera "Carlo Poma", Mantova, Italy
31. Clinical Psychiatry, IRCCS Ospedale Maggiore Policlinico, Milano, Italy
32. Fourth Psychiatric Service, ULSS 20, San Bonifacio, Verona, Italy
33. Second Psychiatric Service,Ospedale Civile Maggiore, ULSS 20, Verona, Italy
34. SPDC c/o Azienda Osp. Naz. Ss Antonio E Biagio-Alessandria, Italy
35. Servizio Psichiatrico di Brunico (BZ), Azienda Sanitaria di Bolzano, Italy
36. Dipartimento di Medicina Clinica e Sperimentale, Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica,Università degli Studi di Perugia, Italy
文摘
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