Table 2

Change from Baseline in CGI-S for three clinical studies of lurasidone in schizophrenia

CGI-S 6-week change from baseline
StudyNumber of patients lurasidone/placeboPlacebo mean (SE)Difference between lurasidone and placebo mean (SE)p Value*
D105004971/72−0.70 (0.11)−0.09 (0.15)0.5950
D105019690/90−0.20 (0.11)−0.41 (0.15)0.0072†
D1050229121/127−1.00 (0.10)−0.40 (0.10)0.0340†
  • *Original p values from the FDA review.

  • †Statistically significant.

  • FDA, Food and Drug Administration; CGI-S, Clinical Global Impressions—Severity Scale.