Table 3.
Change in Secondary Efficacy Measures during Double-Blind Phase (mITT [DB] Analysis Set)
| PP3M | PP1M |
Between Group Difference-LS Means (SE) (95% CI) |
|
|---|---|---|---|
| PANSS total score,a n | N=481 | N=503 | |
| Baseline, mean (SD) | 57.4 (8.56) | 58.1 (8.88) | 0.9 (0.75) |
| Change from baseline, mean (SD) | -3.5 (12.50) | -4.3 (11.78) | (-0.61; 2.34) |
| PANSS subscales scores,a mean (SD) | N=483 | N=512 | |
| Positive subscale | |||
| Baseline | 11.9 (3.12) | 12.0 (3.19) | 0.2 (0.24) (-0.24; 0.72) |
| Change from baseline | -0.6 (4.31) | -0.9 (3.70) | |
| Negative subscale | |||
| Baseline | 17.3 (4.27) | 17.3 (4.11) | -0.0 (0.22) (-0.43; 0.43) |
| Change from baseline | -1.4 (3.63) | -1.4 (3.67) | |
| General psychopathology subscale | |||
| Baseline | 28.2 (4.55) | 28.8 (4.79) | 0.5 (0.41) (-0.31; 1.29) |
| Change from baseline | -1.4 (6.77) | -2.0 (6.57) | |
| PANSS Marder Standardized Factor Scores,a Mean (SD) | |||
| Positive symptoms | |||
| Baseline | 15.7 (3.66) | 15.8 (3.88) | 0.3 (0.27) (-0.21; 0.84) |
| Change from baseline | -1.1 (4.61) | -1.4 (4.16) | |
| Negative symptoms | |||
| Baseline | 16.2 (4.03) | 16.3 (3.90) | -0.0 (0.22) (-0.48; 0.40) |
| Change from baseline | -1.4 (3.57) | -1.3 (3.80) | |
| Disorganized thoughts | |||
| Baseline | 14.2 (3.20) | 14.3 (3.17) | 0.0 (0.20) (-0.35; 0.43) |
| Change from baseline | -1.2 (3.36) | -1.2 (3.24) | |
| Uncontrolled hostility/excitement | |||
| Baseline | 5.2 (1.64) | 5.4 (1.77) | 0.2 (0.14) (-0.03; 0.50) |
| Change from baseline | 0.2 (2.31) | -0.2 (2.21) | |
| Anxiety/depression | |||
| Baseline | 6.1 (2.02) | 6.3 (2.12) | 0.1 (0.15) (-0.15; 0.44) |
| Change from baseline | -0.0 (2.69) | -0.2 (2.43) | |
| CGI-S score,a n | 481 | 504 | |
| Baseline, Mean (SD) | 2.9 (0.57) | 2.9 (0.66) | 0.0 (0.05) (-0.05; 0.13) |
| Change from baseline, Mean (SD) | -0.1 (0.84) | -0.1 (0.75) | |
| PSP Score,a n | 474 | 495 | |
| Baseline, Mean (SD) | 65.5 (10.40) | 65.0 (11.06) | -0.5 (0.60) (-1.73; 0.64) |
| Change from baseline, Mean (SD) | 1.3 (10.22) | 1.9 (9.21) | |
| Improvement in PANSS total, n (%) | N=481 | N=501 | Relative risk (95% CI of relative risk)c |
| ≥20%, | 241 (50.1) | 237 (47.3) |
1.05
(0.93; 1.19) |
| <20% | 240 (49.9) | 264 (52.7) | |
| ≥30% | 175 (36.4) | 181 (36.1) | 0.98 (0.84; 1.16) |
| <30% | 306 (63.6) | 320 (63.9) | |
| ≥40% | 127 (26.4) | 136 (27.1) | 0.95 (0.78; 1.16) |
| <40% | 354 (73.6) | 365 (72.9) | |
| DB 6-month remission statusb, n (%) | N=483 | N=512 | |
| Yes | 282 (58.4) | 303 (59.2) | 0.98 (0.89; 1.08) |
Abbreviations: CGI-S, Clinical Global Impression-Severity; DB, double-blind; OL, open-label; PANSS, Positive and Negative Symptom Scale; PP1M, paliperidone palmitate 1-month formulation; PP3M, paliperidone palmitate 3-month formulation; PSP, Personal and Social Performance.
a Based on ANCOVA model with treatment and country as factors, and baseline value as a covariate.
b Remission is defined as having a score of ≤3 on all of the following 8 PANSS items: P1, P2, P3, N1, N4, N6, G5, and G9 for the last 6 months of DB treatment, with one excursion allowed.
c Point estimate (95% CI) of relative risk (PP3M vs. PP1M) is based on Cochran-Mantel-Haenszel test controlling for country.