Table 2.
Subject Demographics and Bipolar Disorder Characteristics
| |
RCT |
|
|||
|---|---|---|---|---|---|
| |
Ziprasidone |
Placebo |
|
||
| Male | Female | Male | Female | OLE Total | |
| n | 84 | 65 | 47 | 41 | 162 |
| Age (years) | |||||
| Mean±SD | 13.2±2.4 | 14.1±2.0 | 13.5±2.0 | 14.0±1.9 | 13.3 (2.1) |
| Race, n (%) | |||||
| White | 66 (78.6) | 55 (84.6) | 38 (80.9) | 34 (82.9) | 136 (84.0 |
| Black | 15 (17.9) | 6 (9.2) | 8 (17.0) | 6 (14.6) | 18 (11.1) |
| Asian | 0 (0) | 1 (1.5) | 0 (0) | 0 (0) | 1 (0.6) |
| Other | 3 (3.6) | 3 (4.6) | 1 (2.1) | 1 (2.4) | 7 (4.3) |
| Ethnicity, n (%) | |||||
| Hispanic/Latino | 5 (6.0) | 6 (9.2) | 2 (4.3) | 5 (12.2) | 10 (6.2) |
| Not Hispanic | 79 (94.0) | 59 (90.8) | 45 (95.7) | 36 (87.8) | 152 (93.8) |
| Weight (kg) | |||||
| Mean±SD | 55.9±16.3 | 58.8±11.5 | 61.3±17.9 | 58.5±13.4 | 57.4±15.0 |
| Range | 28.0–88.0 | 34.1–94.4 | 29.0–109.4 | 32.1–87.1 | 28.0–94.1 |
| Height (cm) | |||||
| Mean±SD | 160.3±14.1 | 158.1±8.0 | 163.4±13.8 | 157.1±8.1 | 158.6±11.6 |
| Range | 128–188 | 134–174 | 137–193 | 133–170 | 128.0–193.0 |
| Time since first diagnosis (months) | |||||
| Mean | 11.6 | 9.1 | 10 | ||
| Range | 0.0–111.9 | 0.0–103.1 | 0.0–111.9 | ||
| Most recent episode, n | |||||
| Single manic | 14 | 8 | 18 | ||
| Manic | 45 | 23 | 51 | ||
| Mixed | 90 | 57 | 93 | ||
| Comorbid ADHD, n (%) | 66 (44.3) | 36 (40.9) | |||
OLE, open-label extension; RCT, randomized controlled trial; SD, standard deviation; ADHD, attention-deficit/hyperactivity disorder.