Table 4.
Change from Baseline in Children's Depression Rating Scale-Revised Total Score and Clinical Global Impressions-Severity Score in the Open-Label Extension (Mixed-Effects Model for repeated Measures, Intent-to-Treat Population)
| Statistic | Lead-in treatment group |
Total Lead-in N = 314 | Total De novo N = 11 | ||
|---|---|---|---|---|---|
| PBO/VLZ N = 121 | VLZ/VLZ N = 130 | FLX/VLZ N = 63 | |||
| CDRS-R total score at end of treatment period | |||||
| Mean (SD) | 28.5 (11.9) | 29.2 (12.2) | 28.4 (12.2) | 28.8 (12.0) | 35.2 (12.5) |
| Mean change (SD) | −29.2 (12.5) | −30.1 (12.2) | −28.4 (12.2) | −29.6 (12.6) | −24.5 (10.3) |
| CGI-S score at end of treatment period | |||||
| Mean (SD) | 2.1 (1.2) | 2.1 (1.3) | 2.0 (1.2) | 2.1 (1.3) | 2.5 (1.3) |
| Mean change (SD) | −2.5 (1.3) | −2.6 (1.4) | −2.5 (1.4) | −2.5 (1.3) | −1.7 (1.2) |
PBO, placebo; VLZ, vilazodone; FLX, fluoxetine; CGI-S, Clinical Global Impressions-Severity; CDRS-R, Children's Depression Rating Scale-Revised; N, number of patients in the ITT population; SD, standard deviation; MMRM, mixed-effects model for repeated measures; ITT, intent-to-treat.