Table 3.
Results of Analysis of CGI Score: Absolute Values for CGI-I at End of Study and Change From Baseline to End of Study for CGI-S (ITT Population).
| CGI | Placebo (N = 24) | SPN-812 (mg/day) |
|||
|---|---|---|---|---|---|
| 100 (N = 45) | 200 (N = 46) | 300 (N = 47) | 400 (N = 44) | ||
| CGI-I | |||||
| LS meana | 3.0 | 2.6 | 2.6 | 2.2 | 2.4 |
| Placebo-adjusted treatment effectb | — | −0.4 | −0.4 | −0.8 | −0.6 |
| p valueb,c | — | .1305 | .1376 | .0090d | .0546 |
| CGI-S | |||||
| LS meana | −0.8 | −1.4 | −1.5 | −1.6 | −1.7 |
| Placebo-adjusted treatment effectb | — | −0.6 | −0.8 | −0.8 | −0.9 |
| p valueb,c | — | .0708 | .0309d | .0148d | .0136d |
Note. CGI = Clinical Global Impression; CGI-I = Clinical Global Impression-Improvement Scale; CGI-S = Clinical Global Impression-Severity Scale; ITT = intention-to-treat; LS = least squares; ANOVA = analysis of variance.
a
ANOVA including fixed effect for treatment.
b
Comparison between each SPN-812 dose group and placebo.
c
Raw (unadjusted for multiplicity) p values.
d
p < .05 versus placebo, estimated by ANOVA.