Table 1.
Baseline demographic and clinical characteristics (safety set)
| Demographic and clinical characteristics | Quetiapine XR + Lithium ( n = 173) | Quetiapine XR + Placebo ( n = 183) | Total ( n = 356) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 37.9 (12.7) | 38.8 (12.1) | 38.3 (12.4) |
| Median | 37.0 | 38.0 | 37.0 |
| Range (min, max) | 18, 64 | 18, 65 | 18, 65 |
| Gender, n (%) | |||
| Male | 101 (58.4) | 121 (66.1) | 222 (62.4) |
| Female | 72 (41.6) | 62 (33.9) | 134 (37.6) |
| Race, n (%) | |||
| White | 98 (56.6) | 102 (55.7) | 200 (56.2) |
| Asian | 73 (42.2) | 78 (42.6) | 151 (42.4) |
| Other | 2 (1.2) | 3 (1.6) | 5 (1.4) |
| Weight (kg) | |||
| Mean (SD) | 69.1 (15.9) | 71.0 (17.1) | 70.1 (16.5) |
| Median | 68.0 | 69.0 | 68.0 |
| Range (min, max) | 37, 120 | 37, 115 | 37, 120 |
| BMI (kg/m2) | |||
| Mean (SD) | 24.3 (4.3) | 24.9 (5.2) | 24.6 (4.8) |
| Median | 23.8 | 24.1 | 23.9 |
| Range (min, max) | 15.8, 37.1 | 14.7, 43.8 | 14.7, 43.8 |
| Psychiatric diagnosis, n (%) | |||
| Most recent episode manic | 159 (91.8) | 173 (94.5) | 332 (93.3) |
| Most recent episode mixed | 14 (8.1) | 10 (5.5) | 24 (6.7) |
| Rapid cycling, n (%) | |||
| Yes | 3 (1.7) | 5 (2.7) | 8 (2.2) |
| No | 170 (98.3) | 178 (97.3) | 348 (97.8) |
| Time since first diagnosis of acute mania, years | |||
| Mean (SD) | 7.1 (6.6) | 7.8 (7.0) | 7.5 (6.8) |
| Time since first mania/mixed episode, years | |||
| Mean (SD) | 7.2 (6.6) | 8.1 (7.0) | 7.7 (6.8) |
| Total number of mania/mixed episodes in the past year, n (%) | |||
| 0 | 56 (32.4) | 56 (30.6) | 112 (31.5) |
| 1 | 88 (50.9) | 88 (48.1) | 176 (49.4) |
| ≥ 2 | 29 (16.8) | 39 (21.3) | 68 (19.1) |
| Previous medication use, n (%) | |||
| Lithium | 4 (2.3) | 2 (1.1) | 6 (1.7) |
| Quetiapine | 8 (4.6) | 17 (9.3) | 25 (7.0) |