Table 3.
Change in secondary efficacy measures from baseline to week 13 (full analysis set)
| Paliperidone palmitate N =610
|
|||||
|---|---|---|---|---|---|
| Change from baseline
| |||||
| Baseline | Week 1 | Week 5 | Week 9 | Week 13 | |
| PANSS total score, mean (SD) | 91.8 (12.5) | −9.7 (10.6)* | −20.5 (15.45)* | −26.3 (17.81)* | −30.9 (19.5)* |
| PANSS subscale scores, mean (SD) | |||||
| Positive subscale | 24.2 (5.5) | −3.0 (3.6)* | −6.7 (5.4)* | −8.5 (6.0)* | −9.9 (6.5)* |
| Negative subscale | 23.1 (6.2) | −2.0 (3.36)* | −4.5 (4.7)* | −5.8 (5.5)* | −7.0 (6.0)* |
| General pathophysiology | 44.6 (7.1) | −4.6 (5.77)* | −9.3 (7.9)* | −12.0 (9.0)* | −14.0 (9.9)* |
| PANSS Marder standardized factor scores, mean (SD) | |||||
| Positive symptoms | 28.9 (5.2) | −3.0 (3.73)* | −6.9 (5.7)* | −9.0 (6.5)* | −10.7 (7.1)* |
| Negative symptoms | 23.4 (6.4) | −2.1 (3.51)* | −4.5 (4.9)* | −6.0 (5.7)* | −7.1 (6.3)* |
| Disorganized thoughts | 18.9 (4.4) | −1.7 (2.66)* | −3.7 (3.7)* | −4.8 (4.3)* | −5.7 (4.8)* |
| Uncontrolled hostility/excitement | 11.5 (4.0) | −1.9 (2.77)* | −3.5 (3.6)* | −4.2 (3.9)* | −4.7 (4.0)* |
| Anxiety/depression | 9.0 (3.2) | −1.0 (1.88)* | −1.9 (2.4)* | −2.4 (2.8)* | −2.7 (3.1)* |
| CGI−S score, mean (SD) | 5.3 (0.7) | −0.5 (0.73)* | −1.2 (1.05)* | −1.5 (1.18)* | −1.8 (1.3)* |
| PSP score, mean (SD) | 44.9 (13.7) | 13.1 (14.15)* | 19.3 (16.3)* | ||
| Socially useful activities, including work and study, n (%) | |||||
| Absent | 1 (0.2) | 3 (0.5)* | 33 (5.7)* | ||
| Mild | 32 (5.2) | 128 (22.5)* | 207 (35.6)* | ||
| Manifest | 113 (18.5) | 195 (34.3)* | 198 (34.1)* | ||
| Marked | 301 (49.3) | 186 (32.7)* | 113 (19.4)* | ||
| Severe | 157 (25.7) | 55 (9.7)* | 28 (4.8)* | ||
| Very severe | 6 (1.0) | 2 (0.4)* | 2 (0.3)* | ||
| Personal and social relationships, n (%) | |||||
| Absent | 1 (0.2) | 11 (1.9)* | 50 (8.6)* | ||
| Mild | 43 (7.0) | 129 (22.7)* | 223 (38.4)* | ||
| Manifest | 164 (26.9) | 248 (43.6)* | 204 (35.1)* | ||
| Marked | 293 (48.0) | 158 (27.8)* | 91 (15.7)* | ||
| Severe | 107 (17.5) | 22 (3.9)* | 12 (2.1)* | ||
| Very severe | 2 (0.3) | 1 (0.2)* | 1 (0.2) | ||
| Self−care, n(%) | |||||
| Absent | 57 (9.3) | 119 (20.9)* | 196 (33.7)* | ||
| Mild | 176 (28.9) | 248 (43.6)* | 260 (44.8)* | ||
| Manifest | 222 (36.4) | 160 (28.1)* | 100 (17.2)* | ||
| Marked | 127 (20.8) | 37 (6.5)* | 21 (3.6)* | ||
| Severe | 26 (4.3) | 5 (0.9)* | 4 (0.7)* | ||
| Very severe | 2 (0.3) | 0* | 0* | ||
| Disturbing and aggressive behaviors, n (%) | |||||
| Absent | 122 (20.0) | 274 (48.2)* | 362 (62.3)* | ||
| Mild | 191 (31.3) | 182 (32.0)* | 143 (24.6)* | ||
| Manifest | 173 (28.4) | 82 (14.4)* | 55 (9.5)* | ||
| Marked | 72 (11.8) | 22 (3.9)* | 16 (2.8)* | ||
| Severe | 46 (7.5) | 7 (1.2)* | 4 (0.7)* | ||
| Very severe | 6 (1.0) | 2 (0.4)* | 1 (0.2)* | ||
| MSQ scores, mean (SD) | 3.9 (1.3) | 1.1 (1.6)* | |||
| MSQ caregiver scores, mean (SD) | 3.9 (1.2) | 1.2 (1.5)* | |||
| IEQ subscales and total scores, mean (SD) | 31.0 (15.5) | −8.4 (16.5) | |||
| Urging | 7.4 (4.2) | −2.3 (4.6) | |||
| Supervision | 8.5 (5.3) | −2.0 (6.1) | |||
| Tension | 6.4 (4.4) | −3.4 (4.6) | |||
| Worrying | 11.0 (5.5) | −2.6 (5.8) | |||
Notes: Wilcoxon signed-rank test on change from baseline for continuous data in PANSS total, subscale and Marder, CGI-S, PSP total, MSQ score, IEQ subscale and total scores, and Bowker test on change from baseline for category data in PSP;
*
P<0.001.
Abbreviations: CGI-S, Clinical Global Impression–Severity; IEQ, involvement evaluation questionnaire; MSQ, Medication Satisfaction Questionnaire; PANSS, Positive and Negative Syndrome scale; PSP, Personal and Social Performance; SD, standard deviation.