A Randomized, Double-Blind, Placebo-Controlled Trial of Vilazodone in Children and Adolescents with Major Depressive Disorder with Twenty-Six-Week Open-Label Follow-Up.

To evaluate the efficacy and long-term safety of vilazodone in children and adolescent outpatients with major depressive disorder (MDD). Children and adolescents aged 7-17 years of age with MDD were randomized 2:2:1 to 8 weeks of double-blind placebo, vilazodone 15 or 30 mg/day or fluoxetine 20 mg/day, respectively. The primary and secondary efficacy outcomes, respectively, were change from baseline to week 8 in Children's Depression Rating Scale-Revised (CDRS-R) score total score and Clinical Global Impressions-Severity (CGI-S) score analyzed using a mixed model for repeated measurement approach. Patients who completed the 8-week randomized controlled trial (RCT), as well as new () patients, could participate in a 26-week, vilazodone-only, open-label extension (OLE) study. The RCT enrolled 473 patients (60% female) with an average age of 13 years. Change in CDRS-R and CGI-S scores from baseline to week 8 did not differ between patients who received vilazodone and those randomized to placebo. The least-squares mean change from baseline in CDRS-R scores was similar for vilazodone and placebo (-20.7 vs. -20.3,  = 0.77; least-squares mean difference [LSMD] = -0.40). For fluoxetine, the LSMD versus placebo was -2.3 ( = 0.14). The OLE enrolled 330 patients (60% female) with an average age of 13-14 years. Overall, no new safety concerns were identified compared to what is known in adults. Similar improvements in depressive symptoms were observed in all arms. This study does not support the efficacy of vilazodone 15 or 30 mg/day for pediatric patients with MDD. No new or unexpected safety concerns were detected during the RCT or OLE studies.