Table 1.
Summary of patient baseline characteristics
| Characteristics | PBO | LY40 | LY80 | RIS | TOTAL | Overall p-Value |
|---|---|---|---|---|---|---|
| ITT Overall Population | N = 295 | N = 292 | N = 280 | N = 142 | N = 1009 | |
| Age, years, mean (SD) | 39.8 (11.4) | 39.6 (11.5) | 40.5 (11.5) | 40.3 (11.1) | 40.0 (11.5) | 0.771 |
| Gender, male, n (%) | 181 (61.4) | 196 (67.1) | 183 (65.4) | 87 (61.3) | 647 (64.1) | 0.422 |
| Ethnicity, n (%) | 0.612 | |||||
| Hispanic or Latino | 13 (4.4) | 11 (3.8) | 15 (5.4) | 9 (6.3) | 48 (4.8) | |
| Not Hispanic or Latino | 282 (95.6) | 281 (96.2) | 265 (94.6) | 133 (93.7) | 961 (95.2) | |
| Race, n (%) | 0.899 | |||||
| American Indian or Alaska Native | 1 (0.3) | 0 (0.0) | 1 (0.4) | 0 (0.0) | 2 (0.2) | |
| Asian | 1 (0.3) | 2 (0.7) | 1 (0.4) | 0 (0.0) | 4 (0.4) | |
| Black or African American | 102 (34.6) | 100 (34.2) | 94 (33.6) | 47 (33.1) | 343 (34.0) | |
| Multiple | 6 (2.0) | 1 (0.3) | 6 (2.1) | 1 (0.7) | 14 (1.4) | |
| Native Hawaiian or Other Pacific Islander | 2 (0.7) | 1 (0.3) | 1 (0.4) | 1 (0.7) | 5 (0.5) | |
| White | 183 (62.0) | 188 (64.4) | 177 (63.2) | 93 (65.5) | 641 (63.6) | |
| Weight (kg), mean (SD) | 81.4 (20.8) | 81.4 (20.4) | 83.3 (19.2) | 82.7 (21.9) | 82.1 (20.4) | 0.622 |
| Duration of Lifetime Illness , years, mean (SD) | 14.5 (10.7) | 14.6 (10.7) | 15.6 (11.0) | 15.2 (10.4) | 14.9 (10.7) | 0.607 |
| Number of Past Psychiatric Hospitalizations, mean (SD) | 8.0 (9.4) | 7.2 (7.3) | 8.2 (8.8) | 7.4 (5.7) | 7.8 (8.2) | 0.439 |
| Simpson-Angus Total Score, mean (SD) | 0.5 (1.4) | 0.4 (1.2) | 0.5 (1.9) | 0.6 (1.7) | 1.5 (1.5) | 0.718 |
| Barnes Akathisia Global Score, mean (SD) | 0.1 (0.5) | 0.1 (0.5) | 0.1 (0.4) | 0.1 (0.4) | 0.1 (0.5) | 0.799 |
| AIMS 1–7 Total Score, mean (SD) | 0.4 (1.2) | 0.2 (1.1) | 0.6 (2.0) | 0.2 (1.0) | 0.4 (1.4) | 0.027 |
| ᅟ | ||||||
| Efficacy-Evaluable ITT Population | N = 267 | N = 267 | N = 253 | N = 132 | N = 919 | |
| PANSS Total Score, mean (SD) | 84.3 (14.8) | 83.7 (14.0) | 84.2 (14.5) | 84.0 (16.2) | 84.1 (14.7) | 0.971 |
Abbreviations: AIMS Abnormal Involuntary Movement Scale, ITT intent-to-treat, kg kilogram, n/N number of patients, PANSS Positive and Negative Syndrome Scale, SD standard deviation.
Groups: PBO = placebo; LY40 = LY2140023 monohydrate 40 mg; LY80 = LY2140023 monohydrate 80 mg; RIS = risperidone.