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Neuropsychopharmacology (1996) 14 111-123.
Olanzapine versus Placebo and Haloperidol
Acute Phase Results of the North American Double-Blind Olanzapine Trial
Charles M Beasley Jr M.D, Gary Tollefson MD, Ph.D, Pierre Tran MD, Winston Satterlee MD, Todd Sanger Ph.D and Susan Hamilton MS |
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From the Psychopharmacology Division, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center 2128, Indianapolis, Indiana
Correspondence: Dr Charles M Beasley, Jr, Eli Lilly and Company, Lilly Corporate Center 2128, Indianapolis, IN 46285
For a complete listing of The olanzapine HGAD Study Group see Appendix at end of article text.
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ABSTRACT
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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.
Keywords: Olanzapine; Placebo; Haloperidol; Acute; Double-blind; Atypical; Schizophrenia; Antipsychotic |
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