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 in the treatment of acute episodes of schizophrenia.


METHODS
Patients with acute exacerbation of schizophrenia (DSM-III-R criteria; n = 158) were allocated on a random, double-blind basis to receive zotepine (150 or 300 mg/day), chlorpromazine (300 or 600 mg/day) or placebo for 8 weeks. Symptoms were assessed on the BPRS, SANS and CGI scales at baseline and weeks 1, 2, 4, 6 and 8 and patients were assessed at these times for adverse effects. Analysis was by analysis of variance on the intent-to-treat population, with last observation carried forward.


RESULTS
Mean BPRS scores improved statistically significantly more with zotepine than chlorpromazine (point estimate of difference -12.4, 95% CI -18.3 to -6.5) or placebo (point estimate of difference -12.7, 95% CI -18.6 to -6.8). Zotepine produced significantly fewer extrapyramidal symptoms (EPS) than chlorpromazine.


CONCLUSIONS
Zotepine is an effective antipsychotic with low propensity for EPS.
Cooper
S J
SJ
Department of Mental Health, The Queen's University of Belfast, Northern Ireland.
Tweed
J
J
Raniwalla
J
J
Butler
A
A
Welch
C
C
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002746:Chlorpromazine / Q000009:adverse effects / Q000627:therapeutic use*; D003988:Dibenzothiepins / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D003988:Dibenzothiepins; C022172:zotepine; D002746:Chlorpromazine