Table 3.
Other Outcomes by Treatment Group (Safety Population)
| Aripiprazole | |||
|---|---|---|---|
| Low dose (n = 42)a | High dose (n = 35)a | Placebo (n = 42)a | |
| LS mean (SE) change from baseline in SNAP-IV inattention average score, week 8b | −0.40 (0.09) | −0.58 (0.09) | −0.23 (0.09) |
| Treatment difference vs. placebo (95% CI) | −0.17 (−0.39 to −0.05) | −0.35 (−0.58 to −0.12) | |
| p-Value | 0.1291 | 0.0027 | |
| LS mean (SE) change from baseline in SNAP-IV hyperactivity/impulsivity average score, week 8b | −0.38 (0.09) | −0.58 (0.09) | −0.35 (0.09) |
| Treatment difference vs. placebo (95% CI) | −0.03 (−0.22 to 0.17) | −0.22 (−00.43 to −0.02) | |
| p-Value | 0.8041 | 0.0352 | |
| LS mean (SE) change from baseline in SNAP-IV ADD/ADHD average score, week 8b | −0.38 (0.08) | −0.57 (0.08) | −0.29 (0.08) |
| Treatment difference vs. placebo (95% CI) | −0.10 (−0.29 to 0.09) | −0.29 (−0.48 to −0.09) | |
| p-Value | 0.3148 | 0.0048 | |
| LS mean (SE) change from baseline in CY-BOCS total score, week 8b | −0.20 (0.56) | −0.74 (0.56) | −0.18 (0.54) |
| Treatment difference vs. placebo (95% CI) | −0.02 (−1.28 to 1.24) | −0.56 (−1.84 to 0.73) | |
| p-Value | 0.9785 | 0.3937 | |
| LS mean (SE) change from baseline in CY-BOCS obsessions total score, week 8b | 0.06 (0.31) | −0.27 (0.32) | 0.14 (0.30) |
| Treatment difference vs. placebo (95% CI) | −0.07 (−0.79 to 0.65) | −0.41 (−1.14 to 0.33) | |
| p-Value | 0.8426 | 0.2774 | |
| LS mean (SE) change from baseline in CY-BOCS compulsions total score, week 8b | −0.20 (0.31) | −0.29 (0.31) | −0.22 (0.30) |
| Treatment difference vs. placebo (95% CI) | 0.02 (−0.67 to 0.70) | −0.07 (−0.77 to 0.64) | |
| p-Value | 0.9549 | 0.8527 | |
| LS mean (SE) change from baseline in CDRS-R total score, week 8b | −2.58 (0.73) | −2.06 (0.73) | −1.80 (0.72) |
| Treatment difference vs. placebo (95% CI) | −0.77 (−2.43 to 0.88) | −0.26 (−1.97 to 1.46) | |
| p-Value | 0.3562 | 0.7679 | |
| LS mean (SE) change from baseline in PARS total score, week 8b | −0.59 (0.62) | −0.88 (0.64) | −1.49 (0.61) |
| Treatment difference vs. placebo (95% CI) | 0.90 (−0.59 to 2.39) | 0.62 (−0.93 to 2.16) | |
| p-Value | 0.2346 | 0.4306 | |
SNAP-IV subscale scores range from 0 to 3, CY-BOCS total score ranges from 0 to 40, CY-BOCS obsessions total and compulsions total scores range from 0 to 25, PARS total score ranges from 0 to 35, and CDRS-R total score ranges from 17 to 113. Higher scores represent a worse condition, and a larger reduction from baseline represents greater improvement.
Number of patients with baseline and week 8 assessment used in the mixed model for repeated-measures analysis.
Derived from a repeated-measures linear model with treatment, week, treatment by week interaction, region, and weight group as fixed categorical effects; the baseline value as a fixed covariate; and the week as the time variable for repeated measures.
ADD/ADHD, attention-deficit disorder/attention-deficit/hyperactivity disorder; CDRS-R, Children's Depression Rating Scale-Revised; C-SSRS, Columbia-Suicide Severity Rating Scale; CY-BOCS, Children's Yale-Brown Obsessive Compulsive Scale; LS, least squares; PARS, Pediatric Anxiety Rating Scale; SE, standard error; SNAP-IV, Swanson, Nolan, and Pelham-IV rating scale.