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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: [email protected] (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.

References

Addington, D., Addington, J., Maticka-Tyndale, E.Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry 1993;163(Suppl. 22):39–44CrossRefGoogle Scholar
American Psychiatric Association, Diagnostic and statistical manual of mental disorders 4th ed.Washington DC, USAAmerican Psychiatric Association 1994Google Scholar
Avorn, J., Bohn, R.L., Mogun, H., Gurwitz, J.H., Monane, M., Everitt, D.E., Walker, A.et al.Neuroleptic drug exposure and treatment of parkinsonism in the elderly: a case–control study. Am J Med 1995;99:48–54CrossRefGoogle ScholarPubMed
Avorn, J., Manane, M., Everitt, D.E., Beers, M.H., Fields, D.et al.Clinical assessments of extrapyramidal signs in nursing home patients given antipsychotic medications. Arch Intern Med 1994;154:1113–1117CrossRefGoogle Scholar
Barak, Y., Shamir, E., Weizman, R.Would a switch from typical antipsychotics to risperidone be beneficial for elderly schizophrenic patients? A naturalistic, long-term, retrospective, comparative study. J Clin Psychopharmacol 2002;22:115–120CrossRefGoogle ScholarPubMed
Barnes, T.R.E.A rating scale for drug-induced akathisia. Br J Psychiatry 1989;154:672–676CrossRefGoogle ScholarPubMed
Berman, I., Merson, A., Rachov-Pavlov, J., Allan, E., Davidson, M., Losonczy, M.F.et al.Risperidone in elderly schizophrenic patients. Am J Geriatr Psychiatry 1996;4:173–179CrossRefGoogle ScholarPubMed
Coulouvrat, C., Dondey-Nouvel, L.Safety of amisulpride (Solian): a review of 11 clinical studies. Int Clin Psychopharmacol 1999;14:209–218Google ScholarPubMed
Davidson, M., Harvey, P.D., Vervarcke, J., Gagiano, C.A., De Hooge, J.D., Bray, G.et al.A long-term, multicenter, open-label study of risperidone in elderly patients with psychosis On behalf of the Risperidone Working Group Int J Geriatr Psychiatry 2000;15:506–5143.0.CO;2-V>CrossRefGoogle ScholarPubMed
Folstein, M.F., Folstein, S.E., McHugh, P.R.“Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189–198Google ScholarPubMed
Hamon-Vilcot, B., Chaufour, S., Deschamps, C., Canal, M., Zieleniuk, I., Ahtoy, P., Chretien, P., Rosenzweig, P., Nasr, A., Piette, F.et al.Safety and pharmacokinetics of a single oral dose of amisulpride in healthy elderly volunteers. Eur J Clin Pharmacol 1998;54:405–409CrossRefGoogle ScholarPubMed
Jeste, D.V., Caligiuri, M.P., Paulsen, J.S., Heaton, R.K., Lacro, J.P., Harris, M.J., Bailey, A., Fell, R.L., McAdams, L.A.et al.Risk of tardive diskinesia in older patients; a prospective longitudinal study of 266 outpatients. Arch Gen Psychiatry 1995;52:756–765CrossRefGoogle Scholar
Kay, S.R., Fiszbein, A., Opler, L.A.The positive and negative syndrome scale for schizophrenia. Schizophr Bull 1987;13:261–276CrossRefGoogle Scholar
Lacro, J.P., Eastham, J.H., Jeste, D.V., Lohr, J.B.et al.Newer antipsychotics and antidepressants for elderly people. Curr Opin Psychiatry 1996;9:290–293CrossRefGoogle Scholar
Lasser, R.A., Bossie, C.A., Zhu, Y., Gharabawi, G., Eerdekens, M., Davidson, M.Efficacy and safety of long-acting risperidone in elderly patients with schizophrenia and schizoaffective disorder. Int J Geriatr Psychiatry 2004;19:898–905CrossRefGoogle ScholarPubMed
Leucht, S., Pitschel-Walz, G., Engel, R.R., Kissling, W.Amisulpride, an unusual “atypical” antipsychotic: a meta-analysis of randomised controlled trials. Am J Psychiatry 2002;59:180–190CrossRefGoogle Scholar
Madhusoodanan, S., Brechker, M., Brenner, R., Kasckow, J., Kunik, M., Negron, A.E., Pomara, N.et al.Risperidone in the treatment of elderly patients with psychotic disorders. Am J Geriatr Psychiatry 1999;7:132–138Google ScholarPubMed
Madhusoodanan, S., Brenner, R., Aroujo, L., Abaza, A.et al.Efficacy of risperidone treatment for psychoses associated with schizophrenia, schizoaffective disorder, bipolar disorder, or senile dementia in 11 geriatric patients: a case series. J Clin Psychiatry 1995;56:514–518Google ScholarPubMed
McKeage, K., Plosker, G.L.Amisulpride: a review of its use in the management of schizophrenia. CNS Drugs 2004;18:933–956CrossRefGoogle ScholarPubMed
National Institute of Mental Health AIMSI, abnormal involuntary movement scaleGuy, W.ECDEU assessment manual of psychopharmacology review Rockville, USANIMH 1976 534–537Google Scholar
Overall, J.E., Gorham, D.R.The brief psychiatric rating scale. Psychol Rep 1962;10:799–812CrossRefGoogle Scholar
Peuskens, J., Bech, P., Möller, H.J., Bale, R., Fleurot, O., Rein, W.et al.Amisulpride vs. risperidone in the treatment of acute exacerbations of schizophrenia. Amisulpride study group. Psychiatry Res 1999;88:107–117CrossRefGoogle ScholarPubMed
Sajatovic, M., Ramirez, L., Vernon, L., Brescan, D., Simon, M., Jurjus, G.et al.Outcome of risperidone therapy in elderly patients with chronic psychosis. Int J Psychiatry Med 1996;26:309–317CrossRefGoogle ScholarPubMed
Salz, B.L., Kane, J.M., Woerner, M.G., Lieberman, J.A., Alvir, J.M., Blank, K., Kahaner, K., Foley, C.et al.Prospective study of tardive dyskinesia in the elderly. Psychopharmacol Bull 1989;25:52–56Google Scholar
Sechter, D., Peuskens, J., Fleurot, O., Rein, W., Lecrubier, Y.Amisulpride vs. risperidone in chronic schizophrenia: results of a 6-month, double-blind study. Neuropsychopharmacology 2002;27:1071–1081CrossRefGoogle Scholar
Simpson, G., Angus, J.A.A rating scale for extrapyramidal side effects. Acta Psychiatr Scand 1970;45(Suppl. 212):11–19Google Scholar
Spina, E., de Leon, J.Metabolic drug interactions with newer antipsychotics: a comparative review. Basic Clin Pharmacol Toxicol 2007;100:4–22CrossRefGoogle ScholarPubMed
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