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A pilot study of the safety and efficacy of amisulpride and risperidone in elderly psychotic patients

Published online by Cambridge University Press:  16 April 2020

M. Riedel ,
F.X. Eich  and
H.J. Möller
M. Riedel*
Affiliation:
Department of Psychiatry, Ludwig-Maximilians-University, Nussbaumstrasse 7, D-80336Munich, Germany
F.X. Eich*
Affiliation:
Sanofi-Aventis, Deutschland GmbH, Berlin, Germany
H.J. Möller*
Affiliation:
Department of Psychiatry, Ludwig-Maximilians-University, Nussbaumstrasse 7, D-80336Munich, Germany
*
*Corresponding author. Tel.: +49 89 516 02 769; fax: +49 89 516 05 188. E-mail address: riedel@med.uni-muenchen.de (M. Riedel).
1For the Amielderly Study Group.
1For the Amielderly Study Group.
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Abstract

Objective

The primary objective of this randomised, active–controlled, parallel group, double-blind study was to evaluate the tolerability of treatment with either amisulpride or risperidone in elderly patients with schizophrenia aged over 65 years; evaluation of efficacy was a secondary objective.

Methods

The study included patients of either sex aged 65 years or older fulfilling DSM IV-diagnostic criteria for psychotic disorders and who presented psychotic symptoms severe enough to require antipsychotic medication. Subjects were randomly allocated to a flexible dose of either amisulpride (100–400 mg/day) or risperidone (1–4 mg/day) for six weeks following a three- to six-day placebo wash-out period. Safety assessment involved adverse event reporting, physical examination, blood pressure, heart rate and ECG monitoring, and laboratory tests. Extrapyramidal symptoms were evaluated with the Simpson–Angus Scale, Barnes Akathisia Scale and the AIMS. Efficacy parameters were changes in score on the PANSS, BPRS, CDS and MMSE scores.

Results

Thirty-eight patients were randomised, 25 to amisulpride and 13 to risperidone. A total of 26 adverse events were experienced by 10 patients in the amisulpride group and five patients in the risperidone group. One patient in each group discontinued the study due to the emergence of a movement disorder. Changes in scores on the three measures of extrapyramidal symptoms were similar in the two groups. The PANSS total score decreased by 27.8% in the amisulpride group and by 29% in the risperidone group between inclusion and study end.

Conclusion

Amisulpride and risperidone are generally well tolerated in elderly patients with schizophrenia. Both drugs appeared to be efficacious in this study population, with no differences in efficacy being observed. However, the sample size was too low to reveal potential inter-group differences. Both these atypical antipsychotics thus appear to be suitable for the treatment of schizophrenia in the elderly.

Keywords

AmisulprideRisperidoneSchizophreniaElderlySafetyEfficacy
Type
Original article
Information
European Psychiatry , Volume 24 , Issue 3 , April 2009 , pp. 149 - 153
Copyright
Copyright © Elsevier Masson SAS 2009

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Footnotes

*

Funding support: this study was sponsored and funded by Sanofi–Aventis, manufacturers of amisulpride, who contributed to the study design, oversaw implementation of the study, contributed to the interpretation of the results and initiated and implemented the writing of this manuscript.

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