The safety and efficacy of zotepine in the treatment of schizophrenia: Results of a one-year naturalistic clinical trial

Abstract

INTRODUCTION AND METHOD: The safety and efficacy of zotepine,75 &#45 450 mg/day, were evaluated in an open multicentre one-year study in patients suffering from acute exacerbation of schizophrenia; total exposure amounted to 152.78 years. RESULTS: Mean BPRS total score was reduced from 51.7 at baseline to 40.8 at end-point (P<0.05). Similar significant reductions at all study time-points were recorded for BPRS total and subscores, CGI severity and improvement, BAS total scores and SANS total and global scores. Significant improvements in EPMS and AIMS were recorded from week 12 to end-point. Clinically significant improvements in acute symptoms, detected early in the study, were maintained to end-point. CONCLUSION: Zotepine was well tolerated: weight gain, reduced serum uric acid, raised liver enzymes and increased heart rate were associated with chronic zotepine treatment. Seven patients experienced seizures during the study, although concomitant medications and a known historical predisposition to seizure are factors likely to have contributed to these events. The improvements in negative symptoms and low propensity to cause further extrapyramidal side-effects support the importance of zotepine in maintenance treatment.

• Schizophrenia Maintenance Efficacy Zotepine Long-TERM