Table 3.
| Fluoxetine | Placebo | |||||
|---|---|---|---|---|---|---|
| Relapse (n = 11) | No Relapse (n = 39) | P | Relapse (n = 25) | No Relapse (n = 27) | P | |
| Demographic characteristics | ||||||
| Age, mean (SD) | 11.55 (2.62) | 11.1 (2.7) | .61 | 11.36 (2.80) | 12.15 (2.98) | .33 |
| Male, n (%) | 3 (27.3) | 29 (74.4) | .01 | 17 (68.0) | 16 (59.3) | .57 |
| Female, n (%) | 8 (72.7) | 10 (25.6) | 8 (32.0) | 11 (40.7) | ||
| Caucasian, n (%)c | 7 (63.6) | 27 (69.2) | .72 | 18 (72.0) | 20 (74.1) | .98 |
| Non-Caucasian, n (%)c | 4 (36.4) | 12 (30.8) | 7 (28.0) | 7 (25.9) | ||
| Illness characteristics | ||||||
| Length of episode, mean (SD), wk | 31.1 (30.9) | 20.4 (13.0) | .09 | 26.6 (21.4) | 24.6 (21.2) | .73 |
| Recurrent depression, n (%) | 3 (27.3) | 10 (25.6) | .91 | 8 (32.0) | 7 (25.9) | .63 |
| CDRS total at baseline, mean (SD) | 62.73 (8.13) | 56.03 (5.99) | .004 | 57.28 (6.45) | 58.63 (9.51) | .55 |
| Comorbid conditions | ||||||
| Presence of anxiety, n (%) | 4 (36.4) | 14 (35.9) | .97 | 4 (16.0) | 4 (14.8) | .91 |
| Presence of dysthymia, n (%) | 4 (36.4) | 13 (33.3) | .85 | 13 (52.0) | 4 (14.8) | .005 |
| MASC at baseline, mean (SD) | 65.36 (16.74) | 53.85 (17.6) | .06 | 53.24 (17.8) | 52.11 (22.6) | .84 |
| MASC at week 12, mean (SD) | 49.55 (12.14) | 39.15 (16.9) | .06 | 36.72 (17.0) | 40.59 (16.7) | .41 |
| Family characteristics | ||||||
| SFI-II leadership (patient) at baseline, mean (SD) | 8.4 (2.3) | 6.7 (1.7) | .009 | 8.0 (2.6) | 6.6 (2.2) | .04 |
| SFI-II leadership (parent) at baseline, mean (SD) | 7.5 (1.7) | 6.1 (2.0) | .04 | 7.7 (2.2) | 6.9 (2.4) | .22 |
| Depressive symptoms during treatment | ||||||
| CDRS-R total at week 6, mean (SD) | 32.2 (11.9) | 26.0 (7.0) | .03 | 29.2 (8.2) | 27.3 (8.4) | .41 |
| CDRS-R total at week 12, mean (SD) | 26.9 (2.7) | 22.3 (3.5) | .0002 | 23.1 (4.1) | 21.74 (4.7) | .26 |
| Any residual symptoms at week 12, n (%) | ||||||
| No | 0 (0) | 20 (51.3) | .002 | 11 (44.0) | 17 (63.0) | .26 |
| Yes | 11 (100) | 19 (48.7) | 14 (56.0) | 10 (37.0) | ||
| Residual insomnia at week 12, n (%) | 6 (54.5) | 3 (7.7) | .0004 | 3 (12.0) | 2 (7.4) | .57 |
| Residual irritability at week 12, n (%) | 7 (63.6) | 3 (7.7) | .0001 | 1 (4.0) | 1 (3.7) | .95 |
Characteristics were compared between relapsers and nonrelapsers within each treatment group using the 2–independent sample t test with the Satterthwaite method for unequal variances (continuous outcomes) and the χ2 test or, when appropriate, Fisher exact test (categorical variables). Note that control variables (covariates for adjustment) were not part of the inferential comparison (test) of the 2 groups (relapsers vs nonrelapsers) on these characteristics via the t test, χ2 test, or Fisher exact test.
Randomization was at week 12; baseline was at week 0.
Race was operationally defined as Caucasian (n = 72, 70.6%) and non-Caucasian = African American (n = 9, 8.8%), Hispanic (n = 15, 14.7%), and other (n = 6, 5.9%).
Abbreviations: CDRS-R = Children’s Depression Rating Scale–Revised, MASC = Multidimensional Anxiety Scale for Children, SFI = Self-Report Family Inventory.