Efficacy and safety of zotepine for the treatment of Taiwanese schizophrenic patients: a double-blind comparison with haloperidol.
OBJECTIVE
Zotepine is claimed to be a neuroleptic drug with atypical features. However, there have been few double-blind studies in Asian patients. The purpose of this study was to compare the efficacy and safety of zotepine and haloperidol in Taiwanese patients with schizophrenia.


METHODS
Patients with positive symptoms (n = 70) were enrolled into this double-blind, randomized study. Each patient received either zotepine 150 mg/day or haloperidol 9 mg/day. The Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression (CGI) were assessed on Days 0, 3, 7, 14, 28, and 42 after the start of treatment. Adverse events were recorded during the trial period. The analyses were carried out on an intent-to-treat basis with the last observation carried forward.


RESULTS
In terms of the score reduction in the PANSS, BPRS, and CGI, all analyses indicated that there were no significant differences between the groups at the end of the trial. Patients who received zotepine had no acute dystonia and less severe parkinsonism (p < 0.05 or 0.10), but significantly more dizziness, body weight gain, and pulse rate increase.


CONCLUSIONS
In this 6-week trial, zotepine at 150 mg/day was as efficacious as haloperidol 9 mg/day in the treatment of Taiwanese patients with schizophrenia. Zotepine treatment produced fewer extrapyramidal symptoms but had a greater frequency of sedative effects compared to haloperidol.
Hwang
T J
TJ
Department of Psychiatry, College of Medicine, National Taiwan University, National Taiwan University Hospital, Taipei, Taiwan.
Lin
S K
SK
Lin
H N
HN
D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003988:Dibenzothiepins / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*
D014150:Antipsychotic Agents; D003988:Dibenzothiepins; D006220:Haloperidol; C022172:zotepine