Table 2.
Efficacy assessments from baseline to end point (LOCF analysis)
| Placebo, n = 83 | Paliperidone palmitate | |||
|---|---|---|---|---|
| Efficacy measure | 234/39 mg, n = 72 | 234/156 mg, n = 72 | 234/234 mg, n = 85 | |
| PANSS total score | ||||
| Baseline, mean (SD) | 92.6 (9.2) | 95.8 (8.9) | 94.5 (7.9) | 96.0 (9.2) |
| LS mean (SE) change from baseline | -9.8 (2.8) | -15.4 (2.7) | -18.7 (2.8) | -20.7 (2.8) |
| P value for LS mean (vs placebo) | -- | 0.046 | 0.001 | <0.001 |
| CGI-S score | ||||
| Baseline, mean (SD) | 5.1 (0.3) | 5.2 (0.4) | 5.1 (0.2) | 5.1 (0.3) |
| LS mean (SE) change from baseline | -0.9 (0.2) | -1.1 (0.2) | -1.3 (0.2) | -1.5 (0.2) |
| P value for LS mean (vs placebo) | -- | 0.387 | 0.023 | 0.003 |
| PSP score | ||||
| Baseline, mean (SD) | 42.9 (10.1) | 41.3 (10.4) | 44.7 (11.5) | 41.0 (10.1) |
| LS mean (SE) change from baseline | 10.3 (2.2) | 11.5 (2.1) | 15.1 (2.2) | 17.7 (2.2) |
| P value for LS mean (vs placebo) | -- | 0.597 | 0.028 | 0.0005 |
Each paliperidone palmitate subject received 234 mg of paliperidone palmitate on day 1 and then their assigned dose day 8 and monthly thereafter.
CGI-S = Clinical Global Impression-Severity scale; LOCF = last-observation-carried-forward; LS = least-squares; PANSS = Positive and Negative Syndrome Scale; PSP = Personal and Social Performance.