Table 1.
Demographic, Baseline Characteristics, and Psychiatric History (ITT-OL and ITT-DB Analysis Sets)
| DB phase (ITT-DB) | |||
|---|---|---|---|
| PP6M (n = 478) | PP3M (n = 224) | Total (n = 702) | |
| Age,a mean (SD), y | 41.2 (11.77) | 40.0 (10.98) | 40.8 (11.53) |
| Sex, n (%) | |||
| Men | 326 (68.2) | 154 (68.8) | 480 (68.4) |
| Race, n (%) | |||
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asianb | 66 (13.8) | 30 (13.4) | 96 (13.7) |
| Black or African American | 49 (10.3) | 23 (10.3) | 72 (10.3) |
| Native Hawaiian or Other Pacific Islander | 3 (0.6) | 0 | 3 (0.4) |
| White | 353 (73.8) | 168 (75.0) | 521 (74.2) |
| Other | 0 | 0 | 0 |
| Multiple | 3 (0.6) | 2 (0.9) | 5 (0.7) |
| Not reported | 4 (0.8) | 1 (0.4) | 5 (0.7) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 75 (15.7) | 25 (11.2) | 100 (14.2) |
| Not Hispanic or Latino | 397 (83.1) | 197 (87.9) | 594 (84.6) |
| Not reported | 6 (1.3) | 2 (0.9) | 8 (1.1) |
| Weight-baseline (OL), mean (SD), kg | 81.9 (16.86) | 80.8 (17.01) | 81.5 (16.90) |
| BMI-baseline (OL), mean (SD), kg/m2 | 27.9 (4.96) | 27.5 (4.96) | 27.7 (4.96) |
| Age at schizophrenia diagnosis, mean (SD), y | 27.7 (9.01) | 27.5 (9.05) | 27.6 (9.02) |
| Prior hospitalization,c n (%) | |||
| N | 356 | 168 | 524 |
| None | 205 (57.6) | 98 (58.3) | 303 (57.8) |
| Once | 97 (27.2) | 47 (28.0) | 144 (27.5) |
| Twice | 37 (10.4) | 18 (10.7) | 55 (10.5) |
| Three times | 11 (3.1) | 4 (2.4) | 15 (2.9) |
| Four times or more | 6 (1.7) | 1 (0.6) | 7 (1.3) |
| PANSS total, n | |||
| Baseline (MA), mean (SD) | 53.1 (9.19) | 52.9 (9.62) | 53.0 (9.33) |
| Baseline (DB), mean (SD) | 51.9 (9.60) | 51.4 (9.77) | 51.7 (9.65) |
| PSP | |||
| Baseline (MA), mean (SD) | 65.6 (12.37) | 65.2 (11.78) | 65.5 (12.18) |
| Baseline (DB), mean (SD) | 66.3 (12.50) | 66.5 (11.82) | 66.4 (12.28) |
| CGI-S | |||
| Baseline (MA), mean (SD) | 3.1 (0.78) | 3.1 (0.76) | 3.1 (0.78) |
| Baseline (DB), mean (SD) | 3.0 (0.78) | 3.0 (0.77) | 3.0 (0.78) |
Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression-Severity; DB, double-blind; ITT, intent-to-treat; MA, maintenance phase; OL, open label; PANSS, Positive and Negative Symptom Scale; PP3M, paliperidone palmitate 3-month formulation; PP6M, paliperidone palmitate 6-month formulation PSP, Personal and Social Performance; SD, standard deviation.
a Age at screening.
b Asian subcategories include Chinese, Korean, Japanese, Filipino, Asian Indian, Thai, Malaysian, and Asian (other).
c Number of hospitalizations for psychosis within 24 months prior to study start.