Table 1. Demographic and Baseline Characteristicsa.
| Characteristic | Lumateperone, 42 mg (n = 150) | Lumateperone, 28 mg (n = 150) | Placebo (n = 149) | Total (N = 449) |
|---|---|---|---|---|
| Demographic characteristics of safety population | ||||
| Male | 110 (73.3) | 113 (75.3) | 123 (82.6) | 346 (77.1) |
| Age, mean (SD), y | 42.4 (10.3) | 43.5 (10.1) | 41.4 (10.3) | 42.4 (10.2) |
| Age ≤40 y | 62 (41.3) | 56 (37.3) | 71 (47.7) | 189 (42.1) |
| Race/ethnicity | ||||
| Black | 108 (72.0) | 94 (62.7) | 96 (64.4) | 298 (66.4) |
| White | 33 (22.0) | 42 (28.0) | 42 (28.2) | 117 (26.1) |
| Other | 9 (6.0) | 14 (9.3) | 11 (7.4) | 34 (7.6) |
| Non-Hispanic/Latino | 137 (91.3) | 133 (88.7) | 135 (90.6) | 405 (90.2) |
| Weight, mean (SD), kg | 86.3 (17.0) | 85.8 (16.7) | 85.9 (17.0) | 86.0 (16.9) |
| BMI, mean (SD) | 28.7 (5.4) | 28.4 (5.1) | 28.2 (5.3) | 28.4 (5.3) |
| Baseline efficacy characteristics in the ITT population | 148 | 146 | 141 | 435 |
| Time since initial schizophrenia diagnosis, mean (SD), y | 16.5 (10,4) | 17.0 (10.6) | 17.4 (10.6) | 17.0 (10.5) |
| PANSS total score, mean (SD) | 90.1 (9.5) | 89.3 (10.2) | 90.1 (11.1) | 89.8 (10.3) |
| PANSS positive symptom subscale score, mean (SD) | 26.0 (3.5) | 25.8 (3.9) | 25.8 (3.9) | 25.9 (3.8) |
| PANSS negative symptom subscale score, mean (SD) | 20.6 (3.8) | 20.4 (4.2) | 21.0 (4.4) | 20.7 (4.1) |
| PANSS general psychopathology subscale score, mean (SD) | 43.5 (6.1) | 43.1 (6.0) | 43.2 (6.3) | 43.3 (6.1) |
| PANSS prosocial subscale score, mean (SD) | 25.0 (3.4) | 24.5 (3.5) | 24.3 (3.3) | 24.6 (3.4) |
| Central CGI-S score, mean (SD) | 4.8 (0.5) | 4.7 (0.6) | 4.8 (0.6) | 4.8 (0.6) |
| Site CGI-S score, mean (SD) | 4.8 (0.6) | 4.8 (0.6) | 4.8 (0.6) | 4.8 (0.6) |
| BPRS score, mean (SD) | 53.7 (7.4) | 53.3 (7.2) | 54.2 (7.7) | 53.7 (7.4) |
| PSP scale score, mean (SD) | 47.8 (11.9) | 48.2 (12.2) | 47.7 (12.4) | 47.9 (12.2) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); BPRS, Brief Psychiatric Rating Scale; CGI-S, Clinical Global Impression–Severity of illness; ITT, intent-to-treat; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance.
a
Data are presented as number (percentage) of study participants unless otherwise indicated.