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Original Article |
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Neuropsychopharmacology (2001) 27 1071-1081.10.1038/S0893-133X(02)00375-5
Amisulpride vs. Risperidone in Chronic Schizophrenia: Results of a 6-month Double-blind Study
Daniel Sechter1, Joseph Peuskens2, Odile Fleurot3, Werner Rein3, Yves Lecrubier4 and The Amisulpride Study Group |
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1Department of Psychiatry, Saint-Jacques Hospital, 2 Place Saint-Jacques, 25030 Besanc¸on ce´dex, France
2Universitair centrum Sint Jozef, Leuvensesteenweg 517, 3070 Kortenberg, Belgium
3Sanofi-Synthelabo Research, 1 avenue Pierre Brossolette, 91385 Chilly Mazarin ce´dex, France
4INSERM, Unite´ 302, Pavillon Cle´rambault, Salpe´trière Hospital, 47 boulevard de l'Hôpital, 75013 Paris, France
Correspondence: Daniel Sechter, Department of Psychiatry, Saint-Jacques Hospital, 2 Place Saint-Jacques, 25030 Besanç on cé dex, France. Tel.: 33.3.81.21.81.52; Fax: 33.3.81.21.88.17; E-mail: daniel.sechter@ufc-chu.univ-fcomte.fr
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ABSTRACT
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This multicenter, double-blind, randomized study evaluated the efficacy, safety and functional effects of two atypical antipsychotics, amisulpride and risperidone, in patients with chronic schizophrenia (DSM IV) with a recent worsening of symptoms. It was planned as a non-inferiority trial. 309 patients received amisulpride (400-1000 mg/day) or risperidone (4-10 mg/day) for six months. Amisulpride was demonstrated to be not inferior to risperidone with respect to the decrease in Positive and Negative Syndrome Scale (PANSS) total score from baseline (90% 2-sided confidence interval (-5.6; 4.0)). Symptomatic improvement measured with the Brief Psychiatry Rating Scale (BPRS), the PANSS positive subscale, and the Bech Rafaelsen Melancholia Scale was similar in both groups. Amisulpride was significantly (p < .05) superior to risperidone in terms of response ( 50% improvement in PANSS and BPRS total scores or "very much/much improved" on the Clinical Global Impression Scale) and also demonstrated better functional effects and subjective response. Both treatments were well tolerated and had a similar low incidence of extrapyramidal symptoms; however, amisulpride was associated with less weight gain and endocrine/sexual symptoms.
Keywords: Antipsychotic; Schizophrenia; Amisulpride; Atypical antipsychotic; Risperidone |
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