MozartV1, PascalFrancis, Corpus, bibRecord, 000099

Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Identifieur interne : 000099 ( PascalFrancis/Corpus ); précédent : 000098; suivant : 000100

Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Auteurs : Emilio Sacchetti ; Alessandro Galluzzo ; Paolo Valsecchi ; Fabio Romeo ; Barbara Gorini ; Lewis Warrington

Source :

Schizophrenia research [ 0920-9964 ] ; 2009.

RBID : Francis:09-0253416

Descripteurs français

Pascal (Inist)
- Ziprasidone, Neuroleptique, Clozapine, Schizophrénie, Pharmacothérapie, Résistance traitement, Homme, Antipsychotique atypique, Psychotrope.

English descriptors

KwdEn :
- Atypical antipsychotic, Clozapine, Human, Neuroleptic, Pharmacotherapy, Psychotropic, Schizophrenia, Treatment resistance, Ziprasidone.

Abstract

This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0920-9964`
A03		`1`		`@0 Schizophr. res.`
A05				`@2 110`
A06				`@2 1-3`
A08	`01`	`1`	`ENG`	`@1 Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study`
A11	`01`	`1`		`@1 SACCHETTI (Emilio)`
A11	`02`	`1`		`@1 GALLUZZO (Alessandro)`
A11	`03`	`1`		`@1 VALSECCHI (Paolo)`
A11	`04`	`1`		`@1 ROMEO (Fabio)`
A11	`05`	`1`		`@1 GORINI (Barbara)`
A11	`06`	`1`		`@1 WARRINGTON (Lewis)`
A14	`01`			`@1 Chair of Psychiatry, Brescia University School of Medicine @2 Brescia @3 ITA @Z 1 aut.`
A14	`02`			`@1 University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili @2 Brescia @3 ITA @Z 1 aut. @Z 2 aut. @Z 3 aut.`
A14	`03`			`@1 Department of Mental Health, Brescia Spedali Civili @2 Brescia @3 ITA @Z 1 aut. @Z 2 aut. @Z 3 aut.`
A14	`04`			`@1 Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO @2 Brescia @3 ITA @Z 1 aut.`
A14	`05`			`@1 Medical Department, Pfizer Italia @2 Rome @3 ITA @Z 4 aut. @Z 5 aut.`
A14	`06`			`@1 Pfizer Inc @2 New York, NY @3 USA @Z 6 aut.`
A20				`@1 80-89`
A21				`@1 2009`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 21734 @5 354000186282640100`
A44				`@0 0000 @1 © 2009 INIST-CNRS. All rights reserved.`
A45				`@0 1 p.1/4`
A47	`01`	`1`		`@0 09-0253416`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Schizophrenia research`
A66	`01`			`@0 NLD`
C01	`01`		`ENG`	@0 This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.
C02	`01`	`X`		`@0 770E03 @1 V`
C02	`02`	`X`		`@0 770D03F01 @1 IV`
C03	`01`	`X`	`FRE`	`@0 Ziprasidone @2 NK @2 FR @5 01`
C03	`01`	`X`	`ENG`	`@0 Ziprasidone @2 NK @2 FR @5 01`
C03	`01`	`X`	`SPA`	`@0 Ziprasidona @2 NK @2 FR @5 01`
C03	`02`	`X`	`FRE`	`@0 Neuroleptique @5 02`
C03	`02`	`X`	`ENG`	`@0 Neuroleptic @5 02`
C03	`02`	`X`	`SPA`	`@0 Neuroléptico @5 02`
C03	`03`	`X`	`FRE`	`@0 Clozapine @2 NK @2 FR @5 03`
C03	`03`	`X`	`ENG`	`@0 Clozapine @2 NK @2 FR @5 03`
C03	`03`	`X`	`SPA`	`@0 Clozapina @2 NK @2 FR @5 03`
C03	`04`	`X`	`FRE`	`@0 Schizophrénie @5 04`
C03	`04`	`X`	`ENG`	`@0 Schizophrenia @5 04`
C03	`04`	`X`	`SPA`	`@0 Esquizofrenia @5 04`
C03	`05`	`X`	`FRE`	`@0 Pharmacothérapie @5 05`
C03	`05`	`X`	`ENG`	`@0 Pharmacotherapy @5 05`
C03	`05`	`X`	`SPA`	`@0 Farmacoterapia @5 05`
C03	`06`	`X`	`FRE`	`@0 Résistance traitement @5 07`
C03	`06`	`X`	`ENG`	`@0 Treatment resistance @5 07`
C03	`06`	`X`	`SPA`	`@0 Resistencia tratamiento @5 07`
C03	`07`	`X`	`FRE`	`@0 Homme @5 18`
C03	`07`	`X`	`ENG`	`@0 Human @5 18`
C03	`07`	`X`	`SPA`	`@0 Hombre @5 18`
C03	`08`	`X`	`FRE`	`@0 Antipsychotique atypique @5 31`
C03	`08`	`X`	`ENG`	`@0 Atypical antipsychotic @5 31`
C03	`08`	`X`	`SPA`	`@0 Antipsicótico atípico @5 31`
C03	`09`	`X`	`FRE`	`@0 Psychotrope @2 FX @5 32`
C03	`09`	`X`	`ENG`	`@0 Psychotropic @2 FX @5 32`
C03	`09`	`X`	`SPA`	`@0 Psicotropo @2 FX @5 32`
C07	`01`	`X`	`FRE`	`@0 Traitement`
C07	`01`	`X`	`ENG`	`@0 Treatment`
C07	`01`	`X`	`SPA`	`@0 Tratamiento`
C07	`02`	`X`	`FRE`	`@0 Antagoniste @5 37`
C07	`02`	`X`	`ENG`	`@0 Antagonist @5 37`
C07	`02`	`X`	`SPA`	`@0 Antagonista @5 37`
C07	`03`	`X`	`FRE`	`@0 Dérivé de la pipérazine @2 FR @5 38`
C07	`03`	`X`	`ENG`	`@0 Piperazine derivatives @2 FR @5 38`
C07	`03`	`X`	`SPA`	`@0 Piperazina derivado @2 FR @5 38`
C07	`04`	`X`	`FRE`	`@0 Récepteur dopaminergique D2 @5 39`
C07	`04`	`X`	`ENG`	`@0 D2 Dopamine receptor @5 39`
C07	`04`	`X`	`SPA`	`@0 Receptor dopaminérgico D2 @5 39`
C07	`05`	`X`	`FRE`	`@0 Récepteur sérotoninergique 5-HT2 @5 40`
C07	`05`	`X`	`ENG`	`@0 5-HT2 Serotonine receptor @5 40`
C07	`05`	`X`	`SPA`	`@0 Receptor serotoninérgico 5-HT2 @5 40`
C07	`06`	`X`	`FRE`	`@0 Psychose @5 41`
C07	`06`	`X`	`ENG`	`@0 Psychosis @5 41`
C07	`06`	`X`	`SPA`	`@0 Psicosis @5 41`
C07	`07`	`X`	`FRE`	`@0 Dérivé de la dibenzodiazépine @4 INC @5 86`
N21				`@1 187`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	FRANCIS 09-0253416 INIST
ET :	Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study
AU :	SACCHETTI (Emilio); GALLUZZO (Alessandro); VALSECCHI (Paolo); ROMEO (Fabio); GORINI (Barbara); WARRINGTON (Lewis)
AF :	Chair of Psychiatry, Brescia University School of Medicine/Brescia/Italie (1 aut.); University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili/Brescia/Italie (1 aut., 2 aut., 3 aut.); Department of Mental Health, Brescia Spedali Civili/Brescia/Italie (1 aut., 2 aut., 3 aut.); Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO/Brescia/Italie (1 aut.); Medical Department, Pfizer Italia/Rome/Italie (4 aut., 5 aut.); Pfizer Inc/New York, NY/Etats-Unis (6 aut.)
DT :	Publication en série; Niveau analytique
SO :	Schizophrenia research; ISSN 0920-9964; Pays-Bas; Da. 2009; Vol. 110; No. 1-3; Pp. 80-89; Bibl. 1 p.1/4
LA :	Anglais
EA :	This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.
CC :	770E03; 770D03F01
FD :	Ziprasidone; Neuroleptique; Clozapine; Schizophrénie; Pharmacothérapie; Résistance traitement; Homme; Antipsychotique atypique; Psychotrope
FG :	Traitement; Antagoniste; Dérivé de la pipérazine; Récepteur dopaminergique D2; Récepteur sérotoninergique 5-HT2; Psychose; Dérivé de la dibenzodiazépine
ED :	Ziprasidone; Neuroleptic; Clozapine; Schizophrenia; Pharmacotherapy; Treatment resistance; Human; Atypical antipsychotic; Psychotropic
EG :	Treatment; Antagonist; Piperazine derivatives; D2 Dopamine receptor; 5-HT2 Serotonine receptor; Psychosis
SD :	Ziprasidona; Neuroléptico; Clozapina; Esquizofrenia; Farmacoterapia; Resistencia tratamiento; Hombre; Antipsicótico atípico; Psicotropo
LO :	INIST-21734.354000186282640100
ID :	09-0253416

Links to Exploration step

Francis:09-0253416

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study</title>
<author><name sortKey="Sacchetti, Emilio" sort="Sacchetti, Emilio" uniqKey="Sacchetti E" first="Emilio" last="Sacchetti">Emilio Sacchetti</name>
<affiliation><inist:fA14 i1="01"><s1>Chair of Psychiatry, Brescia University School of Medicine</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="04"><s1>Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Galluzzo, Alessandro" sort="Galluzzo, Alessandro" uniqKey="Galluzzo A" first="Alessandro" last="Galluzzo">Alessandro Galluzzo</name>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Valsecchi, Paolo" sort="Valsecchi, Paolo" uniqKey="Valsecchi P" first="Paolo" last="Valsecchi">Paolo Valsecchi</name>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Romeo, Fabio" sort="Romeo, Fabio" uniqKey="Romeo F" first="Fabio" last="Romeo">Fabio Romeo</name>
<affiliation><inist:fA14 i1="05"><s1>Medical Department, Pfizer Italia</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Gorini, Barbara" sort="Gorini, Barbara" uniqKey="Gorini B" first="Barbara" last="Gorini">Barbara Gorini</name>
<affiliation><inist:fA14 i1="05"><s1>Medical Department, Pfizer Italia</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Warrington, Lewis" sort="Warrington, Lewis" uniqKey="Warrington L" first="Lewis" last="Warrington">Lewis Warrington</name>
<affiliation><inist:fA14 i1="06"><s1>Pfizer Inc</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">09-0253416</idno>
<date when="2009">2009</date>
<idno type="stanalyst">FRANCIS 09-0253416 INIST</idno>
<idno type="RBID">Francis:09-0253416</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000099</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study</title>
<author><name sortKey="Sacchetti, Emilio" sort="Sacchetti, Emilio" uniqKey="Sacchetti E" first="Emilio" last="Sacchetti">Emilio Sacchetti</name>
<affiliation><inist:fA14 i1="01"><s1>Chair of Psychiatry, Brescia University School of Medicine</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="04"><s1>Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Galluzzo, Alessandro" sort="Galluzzo, Alessandro" uniqKey="Galluzzo A" first="Alessandro" last="Galluzzo">Alessandro Galluzzo</name>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Valsecchi, Paolo" sort="Valsecchi, Paolo" uniqKey="Valsecchi P" first="Paolo" last="Valsecchi">Paolo Valsecchi</name>
<affiliation><inist:fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Romeo, Fabio" sort="Romeo, Fabio" uniqKey="Romeo F" first="Fabio" last="Romeo">Fabio Romeo</name>
<affiliation><inist:fA14 i1="05"><s1>Medical Department, Pfizer Italia</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Gorini, Barbara" sort="Gorini, Barbara" uniqKey="Gorini B" first="Barbara" last="Gorini">Barbara Gorini</name>
<affiliation><inist:fA14 i1="05"><s1>Medical Department, Pfizer Italia</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Warrington, Lewis" sort="Warrington, Lewis" uniqKey="Warrington L" first="Lewis" last="Warrington">Lewis Warrington</name>
<affiliation><inist:fA14 i1="06"><s1>Pfizer Inc</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Schizophrenia research</title>
<title level="j" type="abbreviated">Schizophr. res.</title>
<idno type="ISSN">0920-9964</idno>
<imprint><date when="2009">2009</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Schizophrenia research</title>
<title level="j" type="abbreviated">Schizophr. res.</title>
<idno type="ISSN">0920-9964</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Atypical antipsychotic</term>
<term>Clozapine</term>
<term>Human</term>
<term>Neuroleptic</term>
<term>Pharmacotherapy</term>
<term>Psychotropic</term>
<term>Schizophrenia</term>
<term>Treatment resistance</term>
<term>Ziprasidone</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Ziprasidone</term>
<term>Neuroleptique</term>
<term>Clozapine</term>
<term>Schizophrénie</term>
<term>Pharmacothérapie</term>
<term>Résistance traitement</term>
<term>Homme</term>
<term>Antipsychotique atypique</term>
<term>Psychotrope</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0920-9964</s0>
</fA01>
<fA03 i2="1"><s0>Schizophr. res.</s0>
</fA03>
<fA05><s2>110</s2>
</fA05>
<fA06><s2>1-3</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>SACCHETTI (Emilio)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>GALLUZZO (Alessandro)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>VALSECCHI (Paolo)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>ROMEO (Fabio)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>GORINI (Barbara)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>WARRINGTON (Lewis)</s1>
</fA11>
<fA14 i1="01"><s1>Chair of Psychiatry, Brescia University School of Medicine</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Mental Health, Brescia Spedali Civili</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO</s1>
<s2>Brescia</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Medical Department, Pfizer Italia</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Pfizer Inc</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA20><s1>80-89</s1>
</fA20>
<fA21><s1>2009</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>21734</s2>
<s5>354000186282640100</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2009 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>1 p.1/4</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>09-0253416</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Schizophrenia research</s0>
</fA64>
<fA66 i1="01"><s0>NLD</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>770E03</s0>
<s1>V</s1>
</fC02>
<fC02 i1="02" i2="X"><s0>770D03F01</s0>
<s1>IV</s1>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Ziprasidone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Ziprasidone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Ziprasidona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Neuroleptique</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Neuroleptic</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Neuroléptico</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Clozapine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Clozapine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Clozapina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Schizophrénie</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Schizophrenia</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Esquizofrenia</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Pharmacothérapie</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Pharmacotherapy</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Farmacoterapia</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Résistance traitement</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Treatment resistance</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Resistencia tratamiento</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Homme</s0>
<s5>18</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Human</s0>
<s5>18</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Hombre</s0>
<s5>18</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Antipsychotique atypique</s0>
<s5>31</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Atypical antipsychotic</s0>
<s5>31</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Antipsicótico atípico</s0>
<s5>31</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Psychotrope</s0>
<s2>FX</s2>
<s5>32</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Psychotropic</s0>
<s2>FX</s2>
<s5>32</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Psicotropo</s0>
<s2>FX</s2>
<s5>32</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Traitement</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Treatment</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Tratamiento</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Antagoniste</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Antagonist</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Antagonista</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Dérivé de la pipérazine</s0>
<s2>FR</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Piperazine derivatives</s0>
<s2>FR</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Piperazina derivado</s0>
<s2>FR</s2>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Récepteur dopaminergique D2</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>D2 Dopamine receptor</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Receptor dopaminérgico D2</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Récepteur sérotoninergique 5-HT2</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>5-HT2 Serotonine receptor</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Receptor serotoninérgico 5-HT2</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Psychose</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Psychosis</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Psicosis</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Dérivé de la dibenzodiazépine</s0>
<s4>INC</s4>
<s5>86</s5>
</fC07>
<fN21><s1>187</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>FRANCIS 09-0253416 INIST</NO>
<ET>Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study</ET>
<AU>SACCHETTI (Emilio); GALLUZZO (Alessandro); VALSECCHI (Paolo); ROMEO (Fabio); GORINI (Barbara); WARRINGTON (Lewis)</AU>
<AF>Chair of Psychiatry, Brescia University School of Medicine/Brescia/Italie (1 aut.); University Psychiatric Unit, Brescia University School of Medicine and Brescia Spedali Civili/Brescia/Italie (1 aut., 2 aut., 3 aut.); Department of Mental Health, Brescia Spedali Civili/Brescia/Italie (1 aut., 2 aut., 3 aut.); Center of Behavioral and Neurodegenerative Disorders, Brescia University and EULO/Brescia/Italie (1 aut.); Medical Department, Pfizer Italia/Rome/Italie (4 aut., 5 aut.); Pfizer Inc/New York, NY/Etats-Unis (6 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Schizophrenia research; ISSN 0920-9964; Pays-Bas; Da. 2009; Vol. 110; No. 1-3; Pp. 80-89; Bibl. 1 p.1/4</SO>
<LA>Anglais</LA>
<EA>This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score ≥80, and CGI-S score >4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0 ± 22.0, 95% CI - 30.2 to -19.8) and clozapine (-24.5 ± 22.5, 95% CI - 29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.</EA>
<CC>770E03; 770D03F01</CC>
<FD>Ziprasidone; Neuroleptique; Clozapine; Schizophrénie; Pharmacothérapie; Résistance traitement; Homme; Antipsychotique atypique; Psychotrope</FD>
<FG>Traitement; Antagoniste; Dérivé de la pipérazine; Récepteur dopaminergique D2; Récepteur sérotoninergique 5-HT2; Psychose; Dérivé de la dibenzodiazépine</FG>
<ED>Ziprasidone; Neuroleptic; Clozapine; Schizophrenia; Pharmacotherapy; Treatment resistance; Human; Atypical antipsychotic; Psychotropic</ED>
<EG>Treatment; Antagonist; Piperazine derivatives; D2 Dopamine receptor; 5-HT2 Serotonine receptor; Psychosis</EG>
<SD>Ziprasidona; Neuroléptico; Clozapina; Esquizofrenia; Farmacoterapia; Resistencia tratamiento; Hombre; Antipsicótico atípico; Psicotropo</SD>
<LO>INIST-21734.354000186282640100</LO>
<ID>09-0253416</ID>
</server>
</inist>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Musique/explor/MozartV1/Data/PascalFrancis/Corpus

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000099 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 000099 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Musique
   |area=    MozartV1
   |flux=    PascalFrancis
   |étape=   Corpus
   |type=    RBID
   |clé=     Francis:09-0253416
   |texte=   Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study
}}

This area was generated with Dilib version V0.6.20.
Data generation: Sun Apr 10 15:06:14 2016. Site generation: Tue Feb 7 15:40:35 2023

	Serveur d'exploration sur Mozart
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur Mozart

Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Source :

Descripteurs français

English descriptors

Abstract

Notice en format standard (ISO 2709)

Format Inist (serveur)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri