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Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial.
Am J Psychiatry. 1997 Apr; 154(4):457-65.AJ

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.

Authors+Show Affiliations

Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9090331

Citation

Tollefson, G D., et al. "Olanzapine Versus Haloperidol in the Treatment of Schizophrenia and Schizoaffective and Schizophreniform Disorders: Results of an International Collaborative Trial." The American Journal of Psychiatry, vol. 154, no. 4, 1997, pp. 457-65.
Tollefson GD, Beasley CM, Tran PV, et al. Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial. Am J Psychiatry. 1997;154(4):457-65.
Tollefson, G. D., Beasley, C. M., Tran, P. V., Street, J. S., Krueger, J. A., Tamura, R. N., Graffeo, K. A., & Thieme, M. E. (1997). Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial. The American Journal of Psychiatry, 154(4), 457-65.
Tollefson GD, et al. Olanzapine Versus Haloperidol in the Treatment of Schizophrenia and Schizoaffective and Schizophreniform Disorders: Results of an International Collaborative Trial. Am J Psychiatry. 1997;154(4):457-65. PubMed PMID: 9090331.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Olanzapine versus haloperidol in the treatment of schizophrenia and schizoaffective and schizophreniform disorders: results of an international collaborative trial. AU - Tollefson,G D, AU - Beasley,C M,Jr AU - Tran,P V, AU - Street,J S, AU - Krueger,J A, AU - Tamura,R N, AU - Graffeo,K A, AU - Thieme,M E, PY - 1997/4/1/pubmed PY - 2001/3/28/medline PY - 1997/4/1/entrez SP - 457 EP - 65 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 154 IS - 4 N2 - 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. SN - 0002-953X UR - https://www.unboundmedicine.com/medline/citation/9090331/Olanzapine_versus_haloperidol_in_the_treatment_of_schizophrenia_and_schizoaffective_and_schizophreniform_disorders:_results_of_an_international_collaborative_trial_ DB - PRIME DP - Unbound Medicine ER -