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Article: Clozapine alone versus clozapine and risperidone with refractory schizophrenia

TitleClozapine alone versus clozapine and risperidone with refractory schizophrenia
Authors
Issue Date2006
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2006, v. 354 n. 5, p. 472-482 How to Cite?
AbstractBACKGROUND: The treatment of schizophrenia with multiple antipsychotic drugs is common, but the benefits and risks are not known. METHODS: In a randomized, double-blind study, we evaluated patients with schizophrenia and a poor response to treatment with clozapine. The patients continued to take clozapine and were randomly assigned to receive eight weeks of daily augmentation with 3 mg of risperidone or with placebo. This course of treatment was followed by an optional 18 weeks of augmentation with risperidone. The primary outcome was reduction in the total score for severity of symptoms on the Positive and Negative Syndrome Scale (PANSS). The secondary outcomes included cognitive functioning. RESULTS: A total of 68 patients were randomly assigned to treatment. In the double-blind phase, the mean total score for the severity of symptoms decreased from baseline to eight weeks in both the risperidone and the placebo groups. There was no statistically significant difference in symptomatic benefit between augmentation with risperidone and placebo: 9 of 34 patients receiving placebo and 6 of 34 receiving risperidone responded to treatment (P = 0.38). The mean difference in the change in PANSS scores from baseline to eight weeks between those receiving risperidone and those receiving placebo was 0.1 (95 percent confidence interval, -7.3 to 7.0). The verbal working-memory index showed a small decline in the risperidone group and a small improvement in the placebo group (P = 0.02 for the comparison between the two groups in the change from baseline). The increase in fasting blood glucose levels was mildly greater in the risperidone group than in the placebo group (16.2 vs. 1.8 mg per deciliter [0.90 vs. 0.10 mmol per liter], P = 0.04). The incidence and severity of other side effects did not differ between the two groups. CONCLUSIONS: In this short-term study, the addition of risperidone to clozapine did not improve symptoms in patients with severe schizophrenia. (ClinicalTrials.gov number, NCT00272584) Copyright © 2006 Massachusetts Medical Society.
Persistent Identifierhttp://hdl.handle.net/10722/45303
ISSN
2023 Impact Factor: 96.2
2023 SCImago Journal Rankings: 20.544
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorHoner, WGen_HK
dc.contributor.authorThornton, AEen_HK
dc.contributor.authorChen, EYHen_HK
dc.contributor.authorChan, RCKen_HK
dc.contributor.authorWong, JOYen_HK
dc.contributor.authorBergmann, Aen_HK
dc.contributor.authorFalkai, Pen_HK
dc.contributor.authorPomarolClotet, Een_HK
dc.contributor.authorMcKenna, PJen_HK
dc.contributor.authorStip, Een_HK
dc.contributor.authorWilliams, Ren_HK
dc.contributor.authorMacEwan, GWen_HK
dc.contributor.authorWasan, Ken_HK
dc.contributor.authorProcyshyn, Ren_HK
dc.date.accessioned2007-10-30T06:22:19Z-
dc.date.available2007-10-30T06:22:19Z-
dc.date.issued2006en_HK
dc.identifier.citationNew England Journal of Medicine, 2006, v. 354 n. 5, p. 472-482en_HK
dc.identifier.issn0028-4793en_HK
dc.identifier.urihttp://hdl.handle.net/10722/45303-
dc.description.abstractBACKGROUND: The treatment of schizophrenia with multiple antipsychotic drugs is common, but the benefits and risks are not known. METHODS: In a randomized, double-blind study, we evaluated patients with schizophrenia and a poor response to treatment with clozapine. The patients continued to take clozapine and were randomly assigned to receive eight weeks of daily augmentation with 3 mg of risperidone or with placebo. This course of treatment was followed by an optional 18 weeks of augmentation with risperidone. The primary outcome was reduction in the total score for severity of symptoms on the Positive and Negative Syndrome Scale (PANSS). The secondary outcomes included cognitive functioning. RESULTS: A total of 68 patients were randomly assigned to treatment. In the double-blind phase, the mean total score for the severity of symptoms decreased from baseline to eight weeks in both the risperidone and the placebo groups. There was no statistically significant difference in symptomatic benefit between augmentation with risperidone and placebo: 9 of 34 patients receiving placebo and 6 of 34 receiving risperidone responded to treatment (P = 0.38). The mean difference in the change in PANSS scores from baseline to eight weeks between those receiving risperidone and those receiving placebo was 0.1 (95 percent confidence interval, -7.3 to 7.0). The verbal working-memory index showed a small decline in the risperidone group and a small improvement in the placebo group (P = 0.02 for the comparison between the two groups in the change from baseline). The increase in fasting blood glucose levels was mildly greater in the risperidone group than in the placebo group (16.2 vs. 1.8 mg per deciliter [0.90 vs. 0.10 mmol per liter], P = 0.04). The incidence and severity of other side effects did not differ between the two groups. CONCLUSIONS: In this short-term study, the addition of risperidone to clozapine did not improve symptoms in patients with severe schizophrenia. (ClinicalTrials.gov number, NCT00272584) Copyright © 2006 Massachusetts Medical Society.en_HK
dc.format.extent175121 bytes-
dc.format.extent3474 bytes-
dc.format.mimetypeapplication/pdf-
dc.format.mimetypetext/plain-
dc.languageengen_HK
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/en_HK
dc.relation.ispartofNew England Journal of Medicineen_HK
dc.rightsFrom New England Journal of Medicine, William G. Honer, Allen E. Thornton, Eric Y.H. Chen, et al., Clozapine alone versus clozapine and risperidone with refractory schizophrenia, vol. 354, p. 472-482. Copyright © 2006 Massachusetts Medical Society. Reprinted with permission.en_HK
dc.subject.meshAntipsychotic Agents - adverse effects - therapeutic useen_HK
dc.subject.meshClozapine - adverse effects - therapeutic useen_HK
dc.subject.meshRisperidone - adverse effects - therapeutic useen_HK
dc.subject.meshSchizophrenia - drug therapyen_HK
dc.subject.meshSchizophrenic Psychologyen_HK
dc.titleClozapine alone versus clozapine and risperidone with refractory schizophreniaen_HK
dc.typeArticleen_HK
dc.identifier.emailChen, EYH: eyhchen@hku.hken_HK
dc.identifier.authorityChen, EYH=rp00392en_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1056/NEJMoa053222en_HK
dc.identifier.pmid16452559-
dc.identifier.scopuseid_2-s2.0-32044464964en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-32044464964&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume354en_HK
dc.identifier.issue5en_HK
dc.identifier.spage472en_HK
dc.identifier.epage482en_HK
dc.identifier.eissn1533-4406-
dc.identifier.isiWOS:000235019400007-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridHoner, WG=7004460814en_HK
dc.identifier.scopusauthoridThornton, AE=7101607212en_HK
dc.identifier.scopusauthoridChen, EYH=7402315729en_HK
dc.identifier.scopusauthoridChan, RCK=35236280300en_HK
dc.identifier.scopusauthoridWong, JOY=12142805600en_HK
dc.identifier.scopusauthoridBergmann, A=7006567126en_HK
dc.identifier.scopusauthoridFalkai, P=7006453025en_HK
dc.identifier.scopusauthoridPomarolClotet, E=8873538700en_HK
dc.identifier.scopusauthoridMcKenna, PJ=7201921663en_HK
dc.identifier.scopusauthoridStip, E=7006409461en_HK
dc.identifier.scopusauthoridWilliams, R=12788026400en_HK
dc.identifier.scopusauthoridMacEwan, GW=6604052646en_HK
dc.identifier.scopusauthoridWasan, K=7006741955en_HK
dc.identifier.scopusauthoridProcyshyn, R=7003797939en_HK
dc.identifier.issnl0028-4793-

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