Abstract
Olanzapine is a potential new “atypical” antipsychotic agent. The double-blind acute phase of this study compared three dosage ranges of olanzapine (5 ± 2.5 mg/day [Olz-L], 10 ± 2.5 mg/day [Olz-M], 15 ± 2.5 mg/day [Olz-H]) to a dosage range of haloperidol (15 ± 5 mg/day [Hal]) and to placebo in the treatment of 335 patients who met the DSM-III-R criteria for schizophrenia. In overall symptomatology improvement (Brief Psychiatric Rating Scale [BPRS]-total), Olz-M, Olz-H, and Hal were significantly superior to placebo. In positive symptom improvement (BPRS-positive), Olz-M, Olz-H, and Hal were comparable and significantly superior to placebo. In negative symptom improvement (Scale for the Assessment of Negative Symptoms [SANS]-composite), Olz-L and Olz-H were significantly superior to placebo and Olz-H was also significantly superior to Hal. The most common treatment-emergent adverse events included somnolence, agitation, asthenia, and nervousness. No acute dystonia was observed with olanzapine. Treatment-emergent parkinsonism occurred with Olz-H at approximately one-third the rate of Hal, and akathisia occurred with Olz-H at approximately one-half the rate of Hal. Prolactin elevations associated with olanzapine were not significantly greater than those observed with placebo and were also significantly less than those seen with haloperidol.
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For a complete listing of The olanzapine HGAD Study Group see Appendix at end of article text.
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Beasley, C., Tollefson, G., Tran, P. et al. Olanzapine versus Placebo and Haloperidol. Neuropsychopharmacol 14, 111–123 (1996). https://doi.org/10.1016/0893-133X(95)00069-P
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DOI: https://doi.org/10.1016/0893-133X(95)00069-P
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