A placebo-controlled comparison of zotepine versus chlorpromazine in patients with acute exacerbation of schizophrenia

Objective: The aim of this study was to evaluate the efficacy of zotepine i n the treatment of acute episodes of schizophrenia. Method: Patients with acute exacerbation of schizophrenia (DSM-III-R criter ia; n = 158) were allocated on a random, double-blind basis to receive zote pine (150 or 300 mg/day), chlorpromazine (300 or 600 mg/ day) or placebo fo r 8 weeks. Symptoms were assessed on the BPRS, SANS and CCI scales at basel ine and weeks 1, 2, 4, 6 and 8 and patients were assessed at these times fo r adverse effects. Analysis was by analysis of variance on the intent-to-tr eat population, with last observation carried forward. Results: Mean BPRS scores improved statistically significantly more with zo tepine than chlorpromazine (point estimate of difference - 12.4, 95% CT - 1 8.3 to - 6.5) or placebo (point estimate of difference - 12.7, 95% CT -18.6 to -6.8). Zotepine produced significantly fewer extrapyramidal symptoms (E PS) than chlorpromazine. Conclusion: Zotepine is an effective antipsychotic with low propensity for EPS.