A COMPARISON OF AN ATYPICAL AND TYPICAL ANTIPSYCHOTIC, ZOTEPINE VERSUS HALOPERIDOL IN PATIENTS WITH ACUTE EXACERBATION OF SCHIZOPHRENIA - APARALLEL-GROUP DOUBLE-BLIND TRIAL

The atypical antipsychotic zotepine was compared to haloperidol in 126 patients suffering from acute exacerbation of schizophrenia (DSM-III- R) in a randomized, double-blind study. After 8-weeks, 150 to 300 mg z otepine improved scores on the Brief Psychiatric Rating Scale (BPRS) m ore than 10 to 20 mg haloperidol (-17.03 versus -13.45; 95% Cl for zot epine-haloperidol -9.34/2.04). BPRS subscores and Clinical Global Impr essions (CGI) Severity and Improvement subscales showed comparable gai ns, but scores on the Scale for the Assessment of Negative Symptoms (S ANS) improved significantly more with zotepine (-23.82) than haloperid ol (-15.15; p<.05; 95% Cl for zotepine-haloperidol -18.03/-0.18), Adve rse events were reported by 71 percent of zotepine and 78 percent of h aloperidol patients, Extrapyramidal side effect (EPMS) scores decrease d with zotepine (-0.34) but increased with haloperidol (+2.32; p<.05). Seven haloperidol patients reported akathisia but no zotepine patient s did (p<.05), Uric acid reductions (which appear to have no clinical consequence) and transient raised liver enzymes were recorded with zot epine, Weight increased on zotepine (2.32 kg; p<.001) and a small incr ease in pulse rate occurred (p<.05). Both drugs were effective in redu cing positive symptoms of schizophrenia; zotepine was significantly mo re effective against negative symptoms and reduced EPMS.