OLANZAPINE VERSUS PLACEBO - RESULTS OF A DOUBLE-BLIND, FIXED-DOSE OLANZAPINE TRIAL

Olanzapine is a potential new ''atypical'' antipsychotic agent. This d ouble-blind, acute phase study compared two doses of olanzapine [1 mg/ day (Olz1.0); 10 mg/day (Olz10.0)] with placebo in the treatment of 15 2 patients who met the DSM-III-R criteria for schizophrenia and had a Brief Psychiatric Rating Scale (BPRS)-total score (items scored 0-6) g reater than or equal to 24. In overall symptomatology improvement [BPR S-total score and Positive and Negative Syndrome Scale (PANSS)-total s core], Olz10.0 was statistically significantly superior to placebo. In positive symptom improvement (PANSS-positive score, BPRS-positive sco re), Olz10.0 was statistically significantly superior to placebo. In n egative symptom improvement (PANSS-negative score), Olz10.0 was statis tically superior to placebo. Olz 1.0 was clinically comparable to plac ebo in all efficacy comparisons. The only adverse event to show an ove rall statistically significant incidence difference was anorexia (repo rted for 10% of placebo-treated and 0% of Olz10.0-treated patients). T he Olz10.0-treated patients improved over baseline with respect to par kinsonian and akathisia symptoms, and these changes were comparable wi th those observed with placebo. There were no dystonias associated wit h Olz10.0 treatment. At endpoint, the incidence of patients with eleva ted prolactin values did not differ statistically significantly betwee n placebo-treated and Olz10.0-treated patients. Olanzapine appears to be not only safe and effective, but a promising atypical antipsychotic candidate.