Assessment methods The following clinical assessments were performed at baseline and 2 hours after IM administration by the psychiatrist who was providing the actual therapy. Therefore, the evaluator was not blind to the patient’s treatment. There were no reliability tests for those who applied PANSS-EC [Kay and Sevy, 1990], the Positive and Negative Syndrome Scale (PANSS) [Kay et al. 1987], the Agitation Calmness Evaluation Scale (ACES), a single-item, 9-point scale (e.g. 1 = marked agitation, 4 = normal behavior, 9 = unarousable) (Copyright © 1998, Eli Lilly and Company; all rights reserved),
the Abnormal Inhibitors,research,lifescience,medical Involuntary Movement Scale (AIMS) [Rush, 2000], the Barnes Akathisia Rating Scale (BARS) [Barnes, 1989] and the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) [Inada, 1996; Inada et al. 1996]. However, assessor Inhibitors,research,lifescience,medical training was provided to ensure a certain degree of reliability. The efficacy outcome was the change in the PANSS score and the change in the ACES score. Meanwhile, AIMS, BARS, DIEPSS, vital signs (pulse and blood pressure) and glucose level were used to investigate safety. Statistical analysis Three Inhibitors,research,lifescience,medical types of statistical analysis were
performed: Comparison of baseline demographics: Fisher’s exact tests and analysis of variance (ANOVA). Change in symptoms over time (within groups): paired t-tests. If the data did not show a normal distribution, Inhibitors,research,lifescience,medical then the Wilcoxon’s signed rank sum test was used instead. Change in symptoms over time (Lapatinib between groups): repeated measures ANOVA of group by time interaction (at baseline and 2 hours after IM administration). The categorical variable is between Inhibitors,research,lifescience,medical groups and the compact variable
is time interaction of each rating scale. The significance level was p < 0.05 in all analyses. Results There was no difference in background characteristics between the IM olanzapine injection group and the IM haloperidol injection group (Table 1). Table 1. Subject characteristics The mean reduction from baseline on the PANSS-EC total score, the PANSS total score and the ACES score were significantly greater in the IM olanzapine injection group than in the IM haloperidol injection group (Table 2, Figure 1). The PANSS positive score decreased significantly Thalidomide from baseline in both the IM olanzapine injection group and the IM haloperidol injection group, but no significant differences were seen between the two groups (Table 2, Figure 1). Table 2. Efficacy and safety. Figure 1. Efficacy and safety. The mean changes from baseline on the AIMS score, the BARS score and the DIEPSS total score were significantly better in the IM olanzapine injection group than in the IM haloperidol injection group (Table 2, Figure 1).