Table 1.
Demographic and Baseline Characteristics, Safety Population
| Children | Adolescents | |||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 42) | Fluoxetine (n = 45) | Desvenlafaxine (n = 43) | Total (n = 130) | Placebo (n = 70) | Fluoxetine (n = 67) | Desvenlafaxine (n = 72) | Total (n = 209) | |
| Age, mean (SD), years | 9.4 (1.3) | 9.6 (1.3) | 9.3 (1.4) | 9.4 (1.3) | 14.6 (1.5) | 14.7 (1.6) | 15.0 (1.5) | 14.8 (1.5) |
| Sex, n (%) | ||||||||
| Female | 23 (55) | 14 (31) | 20 (47) | 57 (44) | 41 (59) | 43 (64) | 43 (60) | 127 (61) |
| Male | 19 (45) | 31 (69) | 23 (53) | 73 (56) | 29 (41) | 24 (36) | 29 (40) | 82 (39) |
| Race, n (%) | ||||||||
| Asian | 1 (2) | 0 | 1 (2) | 2 (2) | 0 | 2 (3) | 0 | 2 (1) |
| Black | 15 (36) | 15 (33) | 14 (33) | 44 (34) | 10 (14) | 19 (28) | 18 (25) | 47 (22) |
| White | 25 (60) | 26 (58) | 23 (53) | 74 (57) | 56 (80) | 41 (61) | 49 (68) | 146 (70) |
| Other | 1 (2) | 4 (9) | 5 (12) | 10 (8) | 4 (6) | 5 (7) | 5 (7) | 14 (7) |
| Height, mean (SD), cm | 140.5 (10.6) | 141.3 (11.2) | 144.3 (11.5) | 142.0 (11.1) | 164.5 (9.8) | 165.8 (8.4) | 167.3 (9.1) | 165.9 (9.2) |
| Weight, mean (SD), kg | 39.4 (14.0) | 44.0 (18.9) | 46.0 (15.2) | 43.2 (16.3) | 68.0 (19.1) | 73.3 (21.8) | 71.7 (19.0) | 71.0 (20.0) |
| BMI, mean (SD), kg/m2 | 19.5 (4.7) | 21.3 (6.4) | 21.6 (5.0) | 20.8 (5.5) | 25.0 (6.0) | 26.5 (6.9) | 25.5 (5.8) | 25.6 (6.3) |
| Duration of most recent episode, median (range), months | 11 (1–57) | 6 (1–42) | 8 (1–71) | 7 (1–71) | 8 (1–69) | 7 (1–96) | 7 (1–61) | 7 (1–96) |
| CDRS-R total score, mean (SD) | 57.0 (8.6) | 55.0 (8.7) | 56.4 (10.9) | 56.1 (9.4) | 57.1 (9.1) | 57.0 (8.1) | 56.3 (8.8) | 56.8 (8.7) |
BMI, body mass index; CDRS-R, Children's Depression Rating Scale–Revised; SD, standard deviation.