Table 1.
Patient baseline demographic characteristics (ATS, acute study screening period)
| Characteristics | PBO/ASN 2.5 mg BID, n=31 | ASN 2.5 mg BID/ASN 2.5 mg BID, n=31 | ASN 5 mg BID/ASN 5 mg BID, n=42 | OLZ 15 mg QD/OLZ 15 mg QD, n=16 |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 18 (58.1) | 18 (58.1) | 25 (59.5) | 10 (62.5) |
| Female | 13 (41.9) | 13 (41.9) | 17 (40.5) | 6 (37.5) |
| Race, n (%) | ||||
| Black | 2 (6.5) | 2 (6.5) | 6 (14.3) | 2 (12.5) |
| White | 29 (93.5) | 29 (93.5) | 36 (85.7) | 14 (87.5) |
| Age (years), mean (SD) | 39.5 (10.1) | 41.1 (9.8) | 39.5 (10.0) | 37.4 (12.5) |
| Weight (kg), mean (SD) | 76.0 (16.1) | 79.7 (16.1) | 75.1 (18.9) | 79.4 (16.5) |
| BMI (kg/m2), mean (SD) | 26.9 (5.2) | 27.3 (4.7) | 25.4 (5.0) | 26.7 (5.0) |
| Abdominal girth (cm), mean (SD) | 90.4 (16.1) | 91.7 (16.7) | 88.9 (14.2) | 90.5 (13.5) |
| Current schizophrenia diagnosis, n (%) | ||||
| Paranoid type | 29 (93.5) | 31 (100.0) | 38 (90.5) | 16 (100.0) |
| Disorganized type | 0 (0.0) | 0 (0.0) | 1 (2.4) | 0 (0.0) |
| Undifferentiated type | 2 (6.5) | 0 (0.0) | 3 (7.1) | 0 (0.0) |
| Duration (years), mean (SD) | 12.1 (9.3) | 10.6 (9.1) | 13.4 (10.0) | 10.1 (7.3) |
| Episodes within the past 12 months (including current), n (%) | ||||
| None | 1 (3.2) | 1 (3.2) | 0 (0.0) | 0 (0.0) |
| 1 | 7 (22.6) | 16 (51.6) | 22 (52.4) | 3 (18.8) |
| 2–3 | 22 (71.0) | 14 (45.2) | 16 (38.1) | 10 (62.5) |
| 4 or more | 1 (3.2) | 0 (0.0) | 4 (9.5) | 3 (18.8) |
| Duration of the current episode (weeks), n (%)a | ||||
| ≤2 | 12 (38.7) | 10 (32.3) | 15 (35.7) | 6 (37.5) |
| >2–≤4 | 11 (35.5) | 11 (35.5) | 18 (42.9) | 4 (25.0) |
| >4–≤6 | 2 (6.5) | 7 (22.6) | 6 (14.3) | 5 (31.3) |
| >6–≤8 | 6 (19.4) | 3 (9.7) | 3 (7.1) | 1 (6.3) |
Note:
a
No current episode was longer than 8 weeks.
Abbreviations: ASN, asenapine; ATS, all-treated set; BID, twice daily; BMI, body mass index; OLZ, olanzapine; PBO, placebo; QD, once daily; SD, standard deviation.