Table 3.
Efficacy Analyses at Week 24 (ITT Population)
| |
Placebo |
Escitalopram |
||
|---|---|---|---|---|
| n | Value | n | Value | |
| Primary efficacy: CDRS-R | ||||
| Baseline score mean±SEM | 157 | 56.0±0.7 | 154 | 57.6±0.7 |
| Change from baseline at week 24, LS mean±SE (LOCF) | 157 | −18.7±1.4 | 154 | −23.1±1.3 |
| Change from baseline at week 24, LS mean±SE (MMRM) | 153 | −24.1±1.4 | 154 | −28.9±1.4 |
| Change from baseline at week 24, LS mean±SE (OC) | 40 | −28.9±1.6 | 39 | −30.4±1.5 |
| Secondary efficacy: CGI-I score | ||||
| Score at week 24, mean±SEM (LOCF) | 157 | 2.5±0.1 | 154 | 2.2±0.1* |
| Score at week 24, mean±SEM (OC) | 40 | 1.5±0.2 | 39 | 1.7±0.1 |
| Additional efficacy measures | ||||
| CGI-S | ||||
| Baseline score mean±SEM | 157 | 4.4±0.0 | 154 | 4.6±0.1 |
| Change from baseline at week 24, LS mean±SE (LOCF) | 157 | −1.4±0.1 | 154 | −1.8±0.1** |
| Change from baseline at week 24, LS mean±SE (OC) | 40 | −2.5±0.2 | 39 | −2.5±0.2 |
| CGAS | ||||
| Baseline score mean±SEM | 157 | 51.9±0.4 | 154 | 51.9±0.5 |
| Change from baseline at week 24, LS mean±SE (LOCF) | 152 | 11.7±1.3 | 149 | 15.3±1.2* |
| Change from baseline at Week 24, LS mean±SE (OC) | 40 | 18.7±2.12 | 39 | 23.7±2.0 |
*
p<0.05; **p<0.01 (based on analysis of covariance [ANCOVA] model).
ITT, intent-to-treat; CDRS-R, Children's Depression Rating Scale-Revised; CGI-I, Clinical Global Impressions-Improvement; CGI-S, CGI-Severity; CGAS, Children's Global Assessment Scale; SE, standard error of least squares [LS] mean; SEM, standard error of the mean; LOCF, last observation carried forward; MMRM, mixed-effects model for repeated measures; OC, observed cases.