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Olanzapine versus clozapine in treatment-resistant or treatment-intolerant schizophrenia.

Abstract

Clozapine has been the gold standard for treatment of patients with refractory schizophrenia but is associated with serious safety liabilities. This has prompted the search for therapeutic alternatives for treatment-resistant schizophrenia. The objective of this study was to compare the efficacy and safety of olanzapine versus clozapine in schizophrenic patients who failed to respond adequately to antipsychotic medication or who experienced intolerable adverse effects associated with the medication. This 18-week, randomized, double-blind, parallel study compared treatment with either olanzapine (5-25 mg/day, n=75) or clozapine (100-500 mg/day, n=72) in patients with schizophrenia who were nonresponsive to, or intolerant of, standard acceptable antipsychotic therapy. At the 18-week endpoint, no statistically significant differences were found between olanzapine and clozapine in any efficacy measure used: Positive and Negative Syndrome Scale (PANSS) total, positive, negative, or general psychopathology or Clinical Global Impression severity (CGI-S). Response rates based on the criteria of Kane et al. [Arch. Gen. Psychiatry 45 (1988) 789] were also not significantly different between olanzapine-treated (57.9%) and clozapine-treated patients (60.8%). There were no significant differences in measurements of extrapyramidal symptoms or electrocardiography, and no clinically and statistically significant changes were seen in vital signs or laboratory measures in either group. Both treatments were well tolerated. Olanzapine demonstrated similar efficacy to clozapine in patients who had failed previous treatment because of lack of efficacy (treatment resistance) or intolerable side effects (treatment intolerance). Olanzapine therefore presents a safe alternative in the treatment of refractory schizophrenia.

Authors+Show Affiliations

Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary. bitter@psych.sote.huNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14687871

Citation

Bitter, Istvan, et al. "Olanzapine Versus Clozapine in Treatment-resistant or Treatment-intolerant Schizophrenia." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 28, no. 1, 2004, pp. 173-80.
Bitter I, Dossenbach MR, Brook S, et al. Olanzapine versus clozapine in treatment-resistant or treatment-intolerant schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2004;28(1):173-80.
Bitter, I., Dossenbach, M. R., Brook, S., Feldman, P. D., Metcalfe, S., Gagiano, C. A., Füredi, J., Bartko, G., Janka, Z., Banki, C. M., Kovacs, G., & Breier, A. (2004). Olanzapine versus clozapine in treatment-resistant or treatment-intolerant schizophrenia. Progress in Neuro-psychopharmacology & Biological Psychiatry, 28(1), 173-80.
Bitter I, et al. Olanzapine Versus Clozapine in Treatment-resistant or Treatment-intolerant Schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2004;28(1):173-80. PubMed PMID: 14687871.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Olanzapine versus clozapine in treatment-resistant or treatment-intolerant schizophrenia. AU - Bitter,Istvan, AU - Dossenbach,Martin R K, AU - Brook,Shlomo, AU - Feldman,Peter D, AU - Metcalfe,Stephen, AU - Gagiano,Carlo A, AU - Füredi,János, AU - Bartko,György, AU - Janka,Zoltan, AU - Banki,Csaba M, AU - Kovacs,Gabor, AU - Breier,Alan, AU - ,, PY - 2003/12/23/pubmed PY - 2004/2/19/medline PY - 2003/12/23/entrez SP - 173 EP - 80 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog Neuropsychopharmacol Biol Psychiatry VL - 28 IS - 1 N2 - Clozapine has been the gold standard for treatment of patients with refractory schizophrenia but is associated with serious safety liabilities. This has prompted the search for therapeutic alternatives for treatment-resistant schizophrenia. The objective of this study was to compare the efficacy and safety of olanzapine versus clozapine in schizophrenic patients who failed to respond adequately to antipsychotic medication or who experienced intolerable adverse effects associated with the medication. This 18-week, randomized, double-blind, parallel study compared treatment with either olanzapine (5-25 mg/day, n=75) or clozapine (100-500 mg/day, n=72) in patients with schizophrenia who were nonresponsive to, or intolerant of, standard acceptable antipsychotic therapy. At the 18-week endpoint, no statistically significant differences were found between olanzapine and clozapine in any efficacy measure used: Positive and Negative Syndrome Scale (PANSS) total, positive, negative, or general psychopathology or Clinical Global Impression severity (CGI-S). Response rates based on the criteria of Kane et al. [Arch. Gen. Psychiatry 45 (1988) 789] were also not significantly different between olanzapine-treated (57.9%) and clozapine-treated patients (60.8%). There were no significant differences in measurements of extrapyramidal symptoms or electrocardiography, and no clinically and statistically significant changes were seen in vital signs or laboratory measures in either group. Both treatments were well tolerated. Olanzapine demonstrated similar efficacy to clozapine in patients who had failed previous treatment because of lack of efficacy (treatment resistance) or intolerable side effects (treatment intolerance). Olanzapine therefore presents a safe alternative in the treatment of refractory schizophrenia. SN - 0278-5846 UR - https://www.unboundmedicine.com/medline/citation/14687871/Olanzapine_versus_clozapine_in_treatment_resistant_or_treatment_intolerant_schizophrenia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(03)00246-X DB - PRIME DP - Unbound Medicine ER -