Table 2.
Change at endpoint in path analysis variables and other clinical measures (path analysis ITT population; n = 1274)
| Parameter | Paliperidone ER daily dose
|
||||||
|---|---|---|---|---|---|---|---|
| 3 mg (n = 120) | 6 mg (n = 224) | 9 mg (n = 243) | 12 mg (n = 238) | 15 mg (n = 112) | Combined (n = 937) | Placebo (n = 337) | |
| Path analysis variables | |||||||
| PANSS negative factor | |||||||
| Baseline, mean (±SD) | 22.3 (5.7) | 23.2 (5.4) | 23.2 (5.1) | 23.6 (5.4) | 23.0 (5.6) | 23.2 (5.4) | 23.1 (5.2) |
| Endpoint (±SD) | 18.5 (6.0) | 18.8 (6.1) | 19.6 (6.1) | 19.1 (6.0) | 18.8 (6.4) | 19.0 (6.1) | 21.6 (6.9) |
| LS mean change (±SE)a | −4.2 (0.6)b | −4.0 (0.4)b | −3.8 (0.4)b | −4.1 (0.4)b | −4.4 (0.6)b | −4.0 (0.2)b | −1.4 (0.3) |
| PANSS positive factor | |||||||
| Baseline (±SD) | 27.6 (4.8) | 27.9 (4.9) | 27.8 (5.2) | 27.6 (4.8) | 27.6 (5.1) | 27.7 (4.9) | 27.8 (4.5) |
| Endpoint (±SD) | 22.5 (7.3) | 21.8 (7.0) | 21.7 (7.7) | 20.4 (6.6) | 20.8 (6.4) | 21.4 (7.1) | 25.4 (7.6) |
| LS mean change (±SE)a | −4.8 (0.7)b | −5.5 (0.5)b | −5.6 (0.4)b | −6.9 (0.5)b | −7.0 (0.7)b | −6.0 (0.2)b | −2.2 (0.4) |
| PANSS anxiety/depression factor | |||||||
| Baseline (±SD) | 10.9 (3.6) | 11.5 (2.9) | 11.2 (3.0) | 11.8 (3.3) | 11.0 (3.2) | 11.4 (3.2) | 11.8 (3.3) |
| Endpoint (±SD) | 9.1 (4.0) | 9.4 (3.5) | 8.9 (3.5) | 9.1 (3.6) | 8.5 (3.6) | 9.0 (3.6) | 10.9 (4.3) |
| LS mean change (±SE)a | −2.0 (0.4)b | −2.0 (0.2)b | −2.2 (0.2)b | −2.5 (0.2)b | −2.8 (0.4)b | −2.3 (0.1)b | −0.8 (0.2) |
| SAS scale | |||||||
| Baseline | 0.20 (0.34) | 0.10 (0.18) | 0.11 (0.21) | 0.10 (0.23) | 0.17 (0.33) | 0.12 (0.25) | 0.14 (0.27) |
| Endpoint | 0.13 (0.29) | 0.06 (0.13) | 0.15 (0.28) | 0.13 (0.25) | 0.15 (0.29) | 0.12 (0.25) | 0.09 (0.24) |
| LS mean change (±SE)a | −0.05 (0.02) | −0.05 (0.01) | 0.03 (0.01)b | 0.02 (0.01)b | 0.00 (0.02) | −0.01 (0.01)c | −0.04 (0.01) |
| Other variables | |||||||
| CGI-S | |||||||
| Baseline (±SD) | 4.7 (0.7) | 4.7 (0.7) | 4.7 (0.7) | 4.8 (0.7) | 4.7 (0.7) | 4.7 (0.7) | 4.7 (0.7) |
| Endpoint (±SD) | 3.9 (1.1) | 3.8 (1.1) | 3.9 (1.1) | 3.7 (1.1) | 3.6 (1.0) | 3.8 (1.1) | 4.4 (1.2) |
| LS mean change (±SE)a | −0.7 (0.1)b | −0.8 (0.1)b | −0.8 (0.1)b | −1.0 (0.1)b | −1.1 (0.1)b | −0.9 (0.0)b | −0.3 (0.1) |
| PSP total score | |||||||
| Baseline (±SD) | 48.3 (14.0) | 46.8 (13.7) | 48.9 (15.2) | 46.0 (13.4) | 47.5 (14.2) | 47.4 (14.1) | 47.6 (13.9) |
| Endpoint (±SD) | 56.9 (17.3) | 56.0 (16.2) | 56.8 (16.6) | 55.4 (15.4) | 59.9 (14.8) | 56.7 (16.1) | 48.6 (17.1) |
| LS mean change (±SE)a | 8.0 (1.5)b | 8.4 (1.0)b | 7.6 (1.0)b | 8.2 (1.0)b | 11.8 (1.6)b | 8.5 (0.5)b | 0.4 (0.8) |
a
ANCOVA model with treatment, study and analysis center within study as factors; the baseline score for the analyzed variable as a covariate.
b
p ≤ 0.001 vs placebo;
c
p < 0.005 vs placebo.
Note: Adjustments for multiple comparisons were not performed.
Abbreviations: CGI-S, Clinical Global Impression-Severity; ER, extended-release; ITT, intent-to-treat; LS, least squares; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance Scale; SAS, Simpson-Angus Rating Scale; SE, standard error.