Table 1.
Demographic and Baseline Characteristics by Treatment and Age Group, Safety Population
| Treatment | Age group | ||||
|---|---|---|---|---|---|
| Placebo (n = 120) | Desvenlafaxine low exposure (n = 122) | Desvenlafaxine high exposure (n = 121) | Children (n = 109) | Adolescents (n = 254) | |
| Age, mean (SD), years | 13.15 (2.68) | 13.07 (2.80) | 12.87 (3.01) | 9.36 (1.32) | 14.61 (1.55) |
| Sex, n (%) | |||||
| Female | 60 (50.0) | 69 (56.56) | 76 (62.81) | 46 (42.20) | 159 (62.60) |
| Male | 60 (50.0) | 53 (43.44) | 45 (37.19) | 63 (57.80) | 95 (37.40) |
| Race, n (%) | |||||
| Asian | 1 (0.83) | 1 (0.82) | 0 | 0 | 2 (0.79) |
| Black | 25 (20.83) | 31 (25.41) | 33 (27.27) | 40 (36.70) | 49 (19.29) |
| White | 85 (70.83) | 86 (70.49) | 78 (64.46) | 59 (54.13) | 190 (74.80) |
| Other | 9 (7.50) | 4 (3.28) | 10 (8.26) | 10 (9.17) | 13 (5.12) |
| Ethnic origin, n (%) | |||||
| Hispanic/Latino | 18 (15.0) | 23 (18.85) | 18 (14.88) | 18 (16.51) | 41 (16.14) |
| Not Hispanic/Latino | 102 (85.0) | 99 (81.15) | 103 (85.12) | 91 (83.49) | 213 (83.86) |
| Height, mean (SD), cm | 159.43 (12.68) | 158.26 (13.18) | 155.80 (14.60) | 141.92 (9.61) | 164.65 (8.24) |
| Weight, mean (SD), kg | 61.39 (22.18) | 58.04 (19.96) | 59.82 (24.12) | 41.94 (14.18) | 67.38 (20.48) |
| BMI, mean (SD), kg/m2 | 23.64 (6.38) | 22.64 (5.45) | 23.96 (7.29) | 20.46 (5.38) | 24.68 (6.43) |
| Duration of current episode, mean (SD), months | 12.85 (12.10) | 11.23 (11.21) | 12.42 (13.24) | 11.39 (11.01) | 12.50 (12.68) |
| Baseline CDRS-R total score, mean (SD) | 57.28 (8.94) | 58.52 (9.18) | 58.45 (9.45) | 56.43 (8.73) | 58.80 (9.30) |
| Baseline CGI-S score, mean (SD) | 4.55 (0.58) | 4.61 (0.61) | 4.61 (0.58) | 4.59 (0.58) | 4.59 (0.59) |
BMI, body mass index; CDRS-R, Children's Depression Rating Scale-Revised; CGI-S, Clinical Global Impressions-Severity; SD, standard deviation.