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Am J Psychiatry 1997; 154:457-465
Copyright © 1997 by American Psychiatric Association
Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial
GD Tollefson, CM Beasley Jr, PV Tran, JS Street, JA Krueger, RN Tamura, KA Graffeo and ME Thieme
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
OBJECTIVE: This international, multicenter double-blind trial was designed
to compare the therapeutic profile of an atypical antipsychotic,
olanzapine, with that of a conventional dopamine D2 antagonist,
haloperidol. METHOD: A total of 1,996 patients at 174 sites in Europe and
North America were randomly assigned to treatment with olanzapine (N =
1,336) or haloperidol (N = 660) over 6 weeks. The primary efficacy analysis
involved the mean change from baseline to endpoint in total scores on the
Brief Psychiatric Rating Scale (BPRS). Secondary analyses included
comparisons of the mean change in positive and negative symptoms, comorbid
depression, extrapyramidal symptoms, and overall drug safety. RESULTS:
Olanzapine demonstrated clinical results superior to those of haloperidol
on overall improvement according to the BPRS and on every secondary
measure, including depression. Olanzapine was also associated with
significantly fewer discontinuations of treatment due to lack of drug
efficacy or adverse events. Substantially more olanzapine-treated patients
(66.5%) than haloperidol-treated patients (46.8%) completed 6 weeks of
therapy. Statistically significant advantages of olanzapine treatment were
related to 1) change in negative symptoms, 2) extrapyramidal symptom
profile, 3) effect on prolactin levels, and 4) response rate. CONCLUSIONS:
Olanzapine shows a superior and broader spectrum of efficacy in the
treatment of schizophrenic psychopathology, with a substantially more
favorable safety profile, than haloperidol. It meets several of the
criteria for a novel atypical antipsychotic agent.
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