Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial - PubMed (original) (raw)
Clinical Trial
. 1997 Apr;154(4):457-65.
doi: 10.1176/ajp.154.4.457.
Affiliations
- PMID: 9090331
- DOI: 10.1176/ajp.154.4.457
Clinical Trial
Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial
G D Tollefson et al. Am J Psychiatry. 1997 Apr.
Abstract
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.
Comment in
- Olanzapine on trial.
Capehart BP, Holsinger T. Capehart BP, et al. Am J Psychiatry. 1998 Jan;155(1):152; author reply 153-5. doi: 10.1176/ajp.155.1.152. Am J Psychiatry. 1998. PMID: 9433357 No abstract available. - Olanzapine on trial.
Barbui C. Barbui C. Am J Psychiatry. 1998 Jan;155(1):152-3; author reply 153-5. doi: 10.1176/ajp.155.1.152a. Am J Psychiatry. 1998. PMID: 9433358 No abstract available. - Olanzapine on trial.
Mattes JA. Mattes JA. Am J Psychiatry. 1998 Jan;155(1):153; author reply 153-5. doi: 10.1176/ajp.155.1.153a. Am J Psychiatry. 1998. PMID: 9433359 No abstract available. - Olanzapine for primary negative symptoms.
Licht RW. Licht RW. Am J Psychiatry. 1998 Aug;155(8):1133-4. doi: 10.1176/ajp.155.8.1133b. Am J Psychiatry. 1998. PMID: 9699711 No abstract available.
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