TABLE 5.
Effect sizes for change based on pooled clinical trial data including all doses of paliperidone extended release combined compared with placebo (N=614)
| SCALE | DAY 4 | WEEK 1 | WEEK 2 | WEEK 3 | WEEK 4 | WEEK 6 |
|---|---|---|---|---|---|---|
| CGI-S-SCA | ||||||
| Overall | 0.16‡ | 0.19‡ | 0.29‡ | 0.22‡ | 0.24‡ | 0.32‡ |
| Positive | 0.19‡ | 0.20‡ | 0.27‡ | 0.14 | 0.13 | 0.30‡ |
| Negative | 0.02 | 0.14 | 0.21‡ | 0.08 | 0.20‡ | 0.21‡ |
| Depression* | 0.09 | 0.13 | 0.29‡ | 0.26‡ | 0.20 | 0.27‡ |
| Manic† | 0.19‡ | 0.23‡ | 0.19 | 0.24‡ | 0.12 | 0.37‡ |
| PANSS | ||||||
| Total | 0.19‡ | 0.25‡ | 0.34‡ | 0.20‡ | 0.20‡ | 0.33‡ |
| Positive | 0.16‡ | 0.21‡ | 0.32‡ | 0.20‡ | 0.18 | 0.37‡ |
| Negative | 0.11 | 0.21‡ | 0.22‡ | 0.12 | 0.17 | 0.21‡ |
| YMRS† | 0.27‡ | 0.27‡ | 0.33‡ | 0.31‡ | 0.2 | 0.43‡ |
| HAM-D-21* | 0.22‡ | 0.23‡ | 0.41‡ | 0.19 | 0.14 | 0.26‡ |
*
Baseline HAM-D-21 ≥16 (n=411)
†
Baseline YMRS ≥16 (n=488)
‡
p<0.05 vs. placebo
- CGI-S-SCA
Clinical Global Impression of Severity for Schizoaffective Disorder;
- HAM-D-21
21-item Hamilton Rating Scale for Depression;
- PANSS
Positive and Negative Syndrome Scale
- YMRS
Young Mania Rating Scale