Randomized Trial of Olanzapine versus Placebo in the Symptomatic Acute Treatment of the Schizophrenic Prodrome.

The present study aimed to determine the short-term efficacy and safety of olanzapine treatment of prodromal symptoms of schizophrenia compared with placebo. This was a double-blind, randomized, parallel-groups, placebo-controlled trial with fixed-flexible dosing, conducted at four sites. Sixty patients met prodromal diagnostic criteria. Olanzapine 5-75 mg daily or placebo was prescribed for 8 weeks. In the mixed-effects, repeated-measures analysis, the treatment by time interaction for the change from baseline on the Scale of Prodromal Symptoms total score was statistically significant, and post hoc analyses revealed that the olanzapine-placebo difference reached significance at week 8. Ratings of extrapyramidal symptoms remained low in each group and were not significantly different. This short-term analysis suggests olanzapine is associated with significantly greater symptomatic improvement but significantly greater weight gain than is placebo in prodromal patients. Extrapyramidal symptoms with olanzapine were minimal and similar to those with placebo. (PsycInfo Database Record (c) 2021 APA, all rights reserved)