Efficacy and safety of novel antipsychotic (AP) drugs (amisulpride, olanzap
ine, quetiapine; ziprasidone and zotepine) have been reviewed. Data on thei
r antipsychotic efficacy and side effects profile have been evaluated only
on the basis of controlled trials so far published. Overall, all these drug
s have shown an antipsychotic efficacy on positive symptoms of schizophreni
a similar to that of the conventional AP drugs. On negative symptoms, all n
ovel AP drugs, except quetiapine and ziprasidone, demonstrated a better eff
icacy than haloperidol. Long-term efficacy of these AP drugs in the mainten
ance treatment of schizophrenia needs to be explored by further, better-des
igned, epidemiological studies. The safety profile shows that the never AP
drugs are generally well-tolerated and induce significantly less acute extr
apyramidal side effects in comparison with haloperidol. Some methodological
flaws in the experimental design of the clinical trials analysed are discu
ssed. Although these novel AP drugs have potential clinical advantages, a n
umber of relevant questions still remain to be addressed, in order to estab
lish the impact of these drugs in the overall treatment of schizophrenia. C
opyright (C) 2000 John Wiley & Sons, Ltd.