Baseline demographics/patient characteristics | Placebo, n = 83 | Paliperidone palmitate | ||
---|---|---|---|---|
 |  | 234/39 mg, n = 72 | 234/156 mg, n = 72 | 234/234 mg, n = 85 |
Age in years, mean (SD) | 40.3 (11.2) | 40.1 (10.2) | 38.4 (10.6) | 39.0 (11.0) |
Sex, n (%) | ||||
   Male | 56 (67.5) | 50 (69.4) | 47 (65.3) | 60 (70.6) |
   Female | 27 (32.5) | 22 (30.6) | 25 (34.7) | 25 (29.4) |
Race, n (%) | ||||
   Caucasian | 39 (47.0) | 40 (55.6) | 35 (48.6) | 40 (47.1) |
   African American | 36 (43.4) | 24 (33.3) | 26 (36.1) | 35 (41.2) |
   Asian | 8 (9.6) | 5 (6.9) | 10 (13.9) | 6 (7.1) |
   Other | 0 (0) | 3 (4.2) | 1 (1.4) | 4 (4.7) |
Age at diagnosis in years, mean (SD) | 24.9 (8.1) | 24.2 (6.8) | 25.8 (8.7) | 24.3 (8.0) |
Baseline PANSS total score, mean (SD) | 92.6 (9.2) | 95.8 (8.9) | 94.5 (7.9) | 96.0 (9.2) |
Baseline CGI-S score, n (%) | ||||
   Marked (= 5) | 73 (88.0) | 60 (83.3) | 68 (94.4) | 74 (87.1) |
   Severe (≥6) | 10 (12.1) | 12 (16.7) | 4 (5.6) | 11 (12.9) |
Prior hospitalization for psychosis, n (%) | ||||
   None | 5 (6.0) | 5 (6.9) | 6 (8.3) | 7 (8.2) |
   1 | 19 (22.9) | 10 (13.9) | 9 (12.5) | 11 (12.9) |
   2 | 16 (19.3) | 13 (18.1) | 18 (25.0) | 17 (20.0) |
   3 | 9 (10.8) | 12 (16.7) | 13 (18.1) | 12 (14.1) |
   ≥4 | 34 (41.0) | 32 (44.4) | 26 (36.1) | 38 (44.7) |
Disposition | ||||
   Completed, n (%) | 32 (38.6) | 35 (48.6) | 36 (50.0) | 43 (50.6) |
   Discontinued, n (%) | 51 (61.5) | 37 (51.4) | 36 (50.0) | 42 (49.4) |
Reasons for discontinuation | ||||
Lack of efficacy | 24 (28.9) | 16 (22.2) | 14 (19.4) | 14 (16.5) |
Withdrew consent | 14 (16.9) | 10 (13.9) | 11 (15.3) | 21 (24.7) |
Adverse event | 7 (8.4) | 6 (8.3) | 7 (9.7) | 5 (5.9) |
Lost to follow-up | 4 (4.8) | 5 (6.9) | 3 (4.2) | 1 (1.2) |
Other | 2 (2.4) | 0 (0) | 1 (1.4) | 1 (1.2) |