Amisulpride vs. risperidone in chronic schizophrenia: results of a 6-month double-blind study.
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 (400-1,000 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.
Sechter
Daniel
D
Department of Psychiatry, Saint-Jacques Hospital, 2 Place Saint-Jacques, 25030 Besançon cédex, France. daniel.sechter@ufc-chu.univ-fcomte.fr
Peuskens
Joseph
J
Fleurot
Odile
O
Rein
Werner
W
Lecrubier
Yves
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D000077582:Amisulpride; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002908:Chronic Disease; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D016037:Single-Blind Method; D013469:Sulpiride / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D013469:Sulpiride; D000077582:Amisulpride; D018967:Risperidone