Change from Baseline in CGI-S for three clinical studies of lurasidone in schizophrenia
| CGI-S 6-week change from baseline | ||||
|---|---|---|---|---|
| Study | Number of patients lurasidone/placebo | Placebo mean (SE) | Difference between lurasidone and placebo mean (SE) | p Value* |
| D1050049 | 71/72 | −0.70 (0.11) | −0.09 (0.15) | 0.5950 |
| D1050196 | 90/90 | −0.20 (0.11) | −0.41 (0.15) | 0.0072† |
| D1050229 | 121/127 | −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.