Table 2.
Change from baseline to endpoint in Positive and Negative Syndrome Scale, Clinical Global Impression of Severity scale, and Personal and Social Performance scale scores for patients in the double‐blind phase with duration of illness ≤5 years
| Double‐blind phase | |||
|---|---|---|---|
| Parameter | Placebo | PP3M | Estimatea |
| n = 54 | n = 61 | ||
| PANSS scores | |||
| Total score | |||
| Baseline, mean (SD) | 54.0 (9.7) | 54.9 (10.9) | |
| Endpoint, mean (SD) | 60.0 (18.3) | 54.6 (13.2) | |
| Change from baseline, mean (SD) | 5.9 (15.3) | −0.3 (7.9) | |
| P valueb | .006 | .783 | |
| Change from baseline, LS mean (SE) | 5.2 (2.1) | −1.9 (2.2) | |
| LS mean difference (95% CI) | 7.1 (2.5, 11.7) | ||
| P value | .003 | ||
| Positive subscale score | |||
| Baseline, mean (SD) | 11.4 (3.1) | 11.4 (3.3) | |
| Endpoint, mean (SD) | 13.9 (6.2) | 11.8 (4.1) | |
| Change from baseline, mean (SD) | 2.5 (5.3) | 0.4 (2.6) | |
| P valueb | .001 | .224 | |
| Change from baseline, LS mean (SE) | 2.7 (0.7) | 0.6 (0.8) | |
| LS mean difference (95% CI) | 2.1 (0.5, 3.7) | ||
| P value | .011 | ||
| Negative subscale score | |||
| Baseline, mean (SD) | 16.1 (4.0) | 16.4 (4.8) | |
| Endpoint, mean (SD) | 16.9 (5.2) | 16.2 (5.0) | |
| Change from baseline, mean (SD) | 0.8 (3.8) | −0.2 (2.9) | |
| P valueb | .115 | .511 | |
| Change from baseline, LS mean (SE) | 0.1 (0.6) | −1.4 (0.6) | |
| LS mean difference (95% CI) | 1.5 (0.2, 2.7) | ||
| P value | .019 | ||
| General psychopathology subscale score | |||
| Baseline, mean (SD) | 26.6 (4.9) | 27.0 (5.1) | |
| Endpoint, mean (SD) | 29.2 (9.6) | 26.6 (6.4) | |
| Change from baseline, mean (SD) | 2.6 (8.3) | −0.4 (4.5) | |
| P valueb | .023 | .445 | |
| Change from baseline, LS mean (SE) | 2.4 (1.2) | −1.2 (1.2) | |
| LS mean difference (95% CI) | 3.6 (1.0, 6.1) | ||
| P value | .006 | ||
| CGI‐S scale score | |||
| Baseline, mean (SD) | 2.8 (0.70) | 2.8 (0.62) | |
| Endpoint, mean (SD) | 3.1 (1.00) | 2.8 (0.88) | |
| Change from baseline, mean (SD) | 0.3 (0.86) | 0.1 (0.60) | |
| P valueb | .021 | .398 | |
| Change from baseline, LS mean (SE) | 0.2 (0.12) | −0.1 (0.13) | |
| LS mean difference (95% CI) | 0.3 (0.0, 0.6) | ||
| P value | .025 | ||
| PSP total score | |||
| Baseline, mean (SD) | 68.1 (9.1) | 69.7 (8.7) | |
| Endpoint, mean (SD) | 64.6 (12.7) | 69.2 (11.8) | |
| Change from baseline, mean (SD) | −3.5 (10.3) | −0.4 (7.2) | |
| P valueb | .016 | .660 | |
| Change from baseline, LS mean (SE) | −3.8 (1.6) | −0.1 (1.6) | |
| LS mean difference (95% CI) | −3.8 (−7.2, −0.4) | ||
| P value | .031 | ||
Abbreviations: CGI‐S, Clinical Global Impression of Severity; PANSS, Positive and Negative Symptom Scale; PP3M, paliperidone palmitate once‐every‐3‐months; PSP, Personal and Social Performance; SD, standard deviation.
a
P values for between‐group comparisons are from an analysis of covariance model with fixed effects for treatment and country and the baseline value as a covariate.
b
P values for within‐group comparisons are based on a paired t ‐ test.