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Clin Drug Investig. 2004;24(5):275-86.

Risperidone versus Conventional Antipsychotics for Schizophrenia and Schizoaffective Disorder : Symptoms, Quality of Life and Resource Use under Customary Clinical Care.

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Risperidone Outcome Study of Effectiveness (ROSE) Group, Janssen Pharmaceutica Inc., Titusville, New Jersey, USA.



To prospectively compare risperidone with conventional antipsychotic agents among schizophrenia patients treated under usual practice conditions.


One-year, multicentre, open-label, randomised trial carried out in 21 centres in 17 states of the US.


684 patients were followed from 1995 to 1997, and must have experienced a symptom relapse at study start.


Patients were randomly assigned to risperidone therapy or their physician's 'best choice' of any one of the 13 conventional antipsychotic medications approved in the US.


Outcomes measured were changes in psychiatric symptoms, side effects, satisfaction with drug therapy, quality of life (including health-related quality of life [HRQOL]) and resource utilisation. A subgroup analysis of the non-switchers was also conducted. Irrespective of treatment group, treatment switching and days with no drug therapy were observed. Compared with patients on conventional antipsychotics, those in the risperidone group achieved statistically superior scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [PANSS total score improved from 83.32 to 61.80 vs 81.42 to 66.99 in the risperidone and conventional groups, respectively), Barnes Akathisia Scale (scores improved from 0.89 to 0.55 vs 0.87 to 0.81 in the risperidone and conventional groups, respectively), and 36-Item Short Form Health Survey (SF-36) scale (scores improved from 32.83 to 39.92 vs 32.55 to 37.22 in the risperidone and conventional groups, respectively) during the 1-year treatment period. A significantly higher percentage of risperidone- treated patients had a 60% improvement in PANSS scores at 12 months (20.9% of patients compared with 10.7% in the risperidone and conventional groups, respectively). There was no statistically significant difference in resource utilisation between the two groups. Among non-switchers, patients in the risperidone group had lower total costs and more clinical benefits.


Conditions of usual practice resulted in a high degree of non-treatment, treatment changing and multi-antipsychotic drug therapy. Patients in the risperidone group had better clinical outcomes (e.g. reduced psychiatric symptoms and side effects) and improved HRQOL. There were no significant differences in healthcare utilisation between the two study groups.

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