Table 3.
Efficacy results for the pooled population (n = 614)a
| Parameter, change from baseline | Week 6 (LOCF) endpoint, ANCOVA |
Week 6 repeated-measures, ANCOVA |
||
|---|---|---|---|---|
| Paliperidone ER | Placebo | Paliperidone ER | Placebo | |
| PANSS scores, LS mean (SE) | n = 414 | n = 200 | n = 278 | n = 115 |
| Total | −26.2 (1.1)b | −18.3 (1.5) | −28.5 (1.1)b | −21.5 (1.6) |
| Positive factor | −8.0 (0.4)b | −5.7 (0.5) | −8.8 (0.4)c | −6.7 (0.5) |
| Negative factor | −4.0 (0.3)b | −2.6 (0.4) | −4.3 (0.3)d | −3.2 (0.4) |
| Anxiety/depression | −4.2 (0.2)c | −3.3 (0.3) | −4.5 (0.2)d | −3.8 (0.3) |
| Disorganized thoughts | −4.6 (0.3)b | −3.0 (0.3) | −5.2 (0.3)c | −3.8 (0.4) |
| Uncontrolled hostility/excitement | −5.4 (0.2)b | −4.0 (0.3) | −6.1 (0.2)b | −4.7 (0.3) |
| CGI-S-SCA, LS mean (SE) | n = 413 | n = 200 | n = 277 | n = 115 |
| Overall | −1.5 (0.1)b | −1.0 (0.1) | −1.7 (0.1)c | −1.3 (0.1) |
| Positive domain | −1.5 (0.1)b | −1.0 (0.1) | −1.8 (0.1)c | −1.4 (0.1) |
| Negative domain | −0.7 (0.1)c | −0.5 (0.1) | −0.8 (0.1) | −0.6 (0.1) |
| Depressive domain | −0.9 (0.1)b | −0.6 (0.1) | −1.0 (0.1)c | −0.7 (0.1) |
| Manic domain | −1.2 (0.1)b | −0.9 (0.1) | −1.3 (0.1)d | −1.0 (0.1) |
| Subjects with YMRS ≥ 16 | n = 328 | n = 160 | n = 219 | n = 93 |
| YMRS total, LS mean (SE) | −14.6 (0.7)b | −9.8 (0.9) | −16.1 (0.7)b | −11.0 (1.0) |
| Subjects with HAM-D-21 ≥ 16 | n = 282 | n = 129 | n = 178 | n = 70 |
| HAM-D-21 total, LS mean (SE) | −12.7 (0.7)b | −8.9 (0.9) | −14.0 (0.6)c | −10.9 (0.9) |
Notes: The repeated-measures mixed-effects ANCOVA model included the baseline score as a fixed-effect covariate; treatment, concomitant medication stratum, country, study, country nested within study, and time (scheduled visit assessment) as fixed-effect (categoric) factors; and treatment by visit interaction. The correlation of the repeated measures is modeled with an unstructured covariance matrix.
The LOCF analysis is based on an ANCOVA model with fixed effects for treatment, study, country nested within study, and the baseline value as a covariate;
P ≤ 0.001, paliperidone ER versus placebo;
P < 0.01, paliperidone ER versus placebo;
P < 0.05, paliperidone ER vs placebo.
Abbreviations: ANCOVA, analysis-of-covariance; CGI-S-SCA, Clinical Global Impressions-Severity-Schizoaffective Disorder; ER, extended-release; LS, least-squares; HAM-D-21, 21-item Hamilton Rating Scale for Depression; LOCF, last-observation-carried-forward; PANSS, Positive and Negative Syndrome Scale; SE, standard error; YMRS, Young Mania Rating Scale.