Table 1.
Baseline Characteristics
| Baseline characteristics | Duloxetine (60 mg QD) n=108 | Duloxetine (30 mg QD) n=116 | Fluoxetine (20 mg QD) n=117 | Placebo n=122 |
|---|---|---|---|---|
| Mean age, y(SD) | 12.9(2.9) | 12.9(2.9) | 13.0(3.2) | 13.1(2.9) |
| Age category, n(%) | ||||
| 7–11 years | 44(40.7) | 49(42.2) | 50(42.7) | 49(40.2) |
| 12–17 years | 64(59.3) | 67(57.8) | 67(57.3) | 73(59.8) |
| Sex, n(%) | ||||
| Female | 60(55.6) | 47(40.5)* | 61(52.1) | 69(56.6) |
| Male | 48(44.4) | 69(59.5)* | 56(47.9) | 53(43.4) |
| BMI | ||||
| Mean(SD) | 23.7(7.2) | 22.5(5.2) | 23.2(6.7) | 24.0(6.8) |
| Median | 21.6 | 21.8 | 21.0 | 22.3 |
| Range (minimum-maximum) | 13.7–50.9 | 14.2–37.7 | 13.4–45.0 | 14.3–48.6 |
| Race, n(%) | ||||
| White | 54(52.9) | 61(54.0) | 67(58.8) | 62(52.1) |
| Native American or Alaska Native | 15(14.7) | 23(20.4) | 16(14.0) | 19(16.0) |
| Black or African American | 27(26.5) | 21(18.6) | 21(18.4) | 24(20.2) |
| Asian | 0(0.0) | 1(0.9) | 1(0.9) | 1(0.8) |
| Native Hawaiian or other Pacific Islander | 0(0.0) | 1(0.9) | 0(0.0) | 0(0.0) |
| Multiracial | 6(5.9) | 6(5.3) | 9(7.9) | 13(10.9) |
| Not provided (n) | 6 | 3 | 3 | 3 |
| Ethnicity, n(%) | ||||
| Hispanic or Latino | 34(31.8) | 38(33.6) | 39(33.6) | 46(38.0) |
| Non-Hispanic or Latino | 73(68.2) | 75(66.4) | 77(66.4) | 75(62.0) |
| Not answered (n) | 1 | 3 | 1 | 1 |
| CDRS-R total score | ||||
| Mean(SD) | 59.3(10.9) | 59.8(11.0) | 57.9(10.1) | 58.2(9.4) |
| CGI-Severity score | ||||
| Mean(SD) | 4.6(0.7) | 4.6(0.7) | 4.6(0.6) | 4.5(0.6) |
*
p<0.05 for gender distribution in the duloxetine 30 mg treatment arm vs. duloxetine 60 mg and placebo (greater proportion of males in the duloxetine 30 mg arm vs. duloxetine 60 mg and placebo).
BMI, body mass index; CDRS-R, Children's Depression Rating Scale-Revised; CGI, Clinical Global Impressions.