Table 2.
Efficacy Results at Study End-Point
| Study measure at end-point | Valproic acid mean (SE) n=21 | Risperidone mean (SE) n=18 | Placebo mean (SE) n=7 | |
|---|---|---|---|---|
| Least squares mean change in YMRS score from baseline | 10.0 (2.46) | 18.82 (1.55) | 4.29 (3.56) | F=3.93, p=0.02 |
| p=0.57 | p=0.001 | p=0.353 | ||
| Percent with Clinical Global Impressions Improvement Scale score of 1 or 2 | 50% | 88% | 0% | χ2=4.97 p=0.08 |
| p=0.008 | p=0.003 | |||
| Cohen's effect size (vs. placebo) | 1.66 | 3.58 | 0.56 | |
| Hazard ratio product-limit survival estimates (status=50% decrease in YMRS) | 1.95 (0.6–6.9) | 6.97 (1.9–25.9) | 0.51 (0.1–1.8) | |
| p=0.30 | p=0.004 | p=0.30 | ||
| Mean change CDRS-from baseline | 2.25 | 2.31 | 0.29 | F=0.44; p=0.64 |
| p=0.06 | p=0.16 | p=0.82 |
YMRS, Young Mania Rating Scale; CDRS, Child Depression Rating Scale.