Table 2.
Double-blind baseline demographics and clinical characteristics
| |
Study active arms |
Study placebo arms |
||
|---|---|---|---|---|
|
PP |
Paliperidone ER |
PP placebo |
Paliperidone ER placebo |
|
| (n = 193) | (n = 104) | (n = 192) | (n = 101) | |
| Age in years, mean (SD) |
38.6 (11.4) |
39.0 (10.7) |
39.2 (10.8) |
37.5 (10.4) |
| Sex, n (%) |
|
|
|
|
| Male |
104 (53.9) |
58 (55.8) |
104 (54.2) |
63 (62.4) |
| Female |
89 (46.1) |
46 (44.2) |
88 (45.8) |
38 (37.6) |
| Race, n (%) |
|
|
|
|
| Caucasian |
124 (64.3) |
62 (59.6) |
126 (65.6) |
61 (60.4) |
| Black |
36 (18.7) |
8 (7.7) |
35 (18.2) |
9 (8.9) |
| Asian |
30 (15.5) |
3 (2.9) |
27 (14.1) |
0 |
| Other |
3 (1.6) |
31 (29.8)a |
4 (2.1) |
31 (30.7)a |
| Age at diagnosis in years, mean (SD) |
26.3 (9.2) |
27.1 (9.2) |
28.2 (8.9) |
25.8 (9.4) |
| Baseline PANSS total score, mean (SD) |
50.8 (11.0) |
51.0 (11.4) |
51.9 (11.1) |
53.4 (10.6) |
| Baseline CGI-S score, n (%) |
|
|
|
|
| Not ill |
11 (5.7) |
6 (5.8) |
11 (5.7) |
5 (5.0) |
| Very mildly ill |
69 (35.8) |
38 (36.5) |
77 (40.1) |
33 (32.7) |
| Mildly ill |
92 (47.7) |
49 (47.1) |
81 (42.2) |
54 (53.5) |
| Moderately ill |
21 (10.9) |
11 (10.6) |
23 (12.0) |
9 (8.9) |
| Previous hospitalisations for psychosis, mean (SD) | 2.6 (1.2)a | 2.9 (1.2)b | 2.7 (1.2)a | 2.9 (1.2)c |
an = 173; bn = 78; cn = 74. CGI-S Clinical Global Impressions–Severity, ER extended release, PANSS Positive and Negative Syndrome Scale, PP paliperidone palmitate, SD standard deviation.