Intention-to-Treat Analysis of Antipsychotic Switching

The intention-to-treat (ITT) population, consisting of all patients who took at least one dose of the study medication and had at least one evaluation for the primary efficacy endpoint after the cross titration period, was used for the efficacy and safety assessment. Subgroup analyses based on the reasons for switching and the previous antipsychotic treatment were also performed. A last observation carried forward (LOCF) approach was applied to handle the missing values for the efficacy analysis. To compare the baseline characteristics between the two subgroups with different reasons for enrolling, the chi-square test or Fisher’s exact test were used for categorical variables and Student’s t test for continuous variables. For the primary and the other efficacy endpoints, a two-way ANOVA with one-way repeated was used to analyze the mean change in PANSS and CGI-S scores between groups. A p value of less than 0.05 was considered to be statistically significant. All statistical analyses were performed with SPSS software version 17 (SPSS Inc., Chicago, IL, USA).