The study was a multi-center, randomized, placebo-controlled, double-blind, phase 3 clinical trial conducted in several countries including Japan, in which a total of 580 adult schizophrenia patients were randomized to three groups that respectively received 40 mg/day (n=196), 80 mg/day (n=194), or placebo (n=190). The study results showed that, regarding the change from baseline at week 6 in the PANSS (Positive and Negative Syndrome Scale) total score (primary endpoint of the study), both the 40 mg/day and 80 mg/day groups showed statistically a significant improvement compared with the placebo group in the modified ITT (Intention-to-Treat) population of 577 subjects. In addition, blonanserin was generally well tolerated, and the adverse events observed in the study, including those related to the skin, were generally mild.
The preliminary results of this study were announced on February 14, 2018.
https://www.nitto.com/jp/en/press/2018/0214.jsp