Table 1. Baseline Characteristicsa.
Characteristic | Placebo n=144 | ABT-126 25 mg n=66 | ABT-126 50 mg n=151 | ABT-126 75 mg n=70 |
---|---|---|---|---|
Age, y, mean (SD) | 42.4 (11.40) | 40.7 (9.92) | 40.1 (12.08) | 40.8 (11.22) |
Sex, n (%) | ||||
Male | 81 (56.3) | 30 (45.5) | 79 (52.3) | 34 (48.6) |
Female | 63 (43.8) | 36 (54.5) | 72 (47.7) | 36 (51.4) |
Race, n (%) | ||||
White | 101 (70.1) | 42 (63.6) | 103 (68.2) | 50 (71.4) |
Black | 40 (27.8) | 22 (33.3) | 45 (29.8) | 17 (24.3) |
All otherb | 3 (2.1) | 2 (3.0) | 3 (2.0) | 3 (4.3) |
Tobacco use, n (%) | ||||
Former | 34 (23.8) | 14 (21.2) | 38 (25.2) | 21 (30.0) |
Never | 109 (76.2) | 52 (78.8) | 113 (74.8) | 49 (70.0) |
Unknown | 1 (0.7) | 0 | 0 | 0 |
Psychiatric history | ||||
Years since schizophrenia diagnosis, mean (SD) | 15.5 (10.57) | 16.0 (9.77) | 13.9 (9.92) | 15.8 (9.94) |
Number of prior psychiatric hospitalizations in last 2 years, n (%) | ||||
0 | 106 (73.6) | 43 (65.2) | 112 (73.7) | 50 (71.4) |
1 | 27 (18.8) | 16 (24.2) | 28 (18.4) | 13 (18.6) |
2 | 10 (6.9) | 4 (6.1) | 9 (5.9) | 7 (10.0) |
3 | 1 (0.7) | 1 (1.5) | 0 | 0 |
4 | 0 | 2 (3.0) | 3 (2.0) | 0 |
Efficacy measures at baseline, mean (SD) | ||||
MCCB neurocognitive composite score | ||||
Primary set | 28.24 (12.91) | — | 28.74 (11.98) | — |
Dose-ranging set | 28.66 (12.34) | 29.13 (12.00) | 29.58 (11.71) | 29.25 (11.59) |
MCCB composite score | ||||
Primary set | 25.25 (13.31) | — | 25.39 (12.31) | — |
Dose-ranging set | 25.71 (12.52) | 26.18 (12.46) | 26.45 (12.07) | 26.24 (11.48) |
UPSA-2ER total scorec | ||||
Primary set | 65.94 (16.23) | — | 65.08 (16.10) | — |
Dose-ranging set | 68.58 (15.05) | 68.31 (14.18) | 65.40 (14.88) | 67.12 (15.20) |
NSA-16 total score | ||||
Primary set | 48.94 (11.34) | — | 48.83 (11.22) | — |
Dose-ranging set | 47.55 (11.19) | 48.10 (11.42) | 48.15 (9.92) | 48.42 (9.21) |
PANSS total score | ||||
Primary set | 66.25 (13.49) | — | 66.95 (13.18) | — |
Dose-ranging set | 64.37 (11.66) | 66.82 (12.49) | 68.34 (12.00) | 66.18 (10.74) |
Abbreviations: MCCB, MATRICS Consensus Cognitive Battery; NSA-16, 16-item version of the Negative Symptom Assessment scale; PANSS, Positive and Negative Symptom Scale; SD, standard deviation; UPSA-2ER, University of California San Diego Performance-based Skills Assessment-2 Extended-Range.
Safety dataset unless otherwise stated.
Includes Asian, multi-race, and Hawaiian native.
Excludes the medication management subscale as it is not included in the ex-US version.