Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.

ABSTRACT: Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo groups showed improvement in MDD symptoms without statistically significant differences between groups. To gain insights on long-term safety and tolerability of vortioxetine in pediatric patients, participants from these two studies were enrolled in two long-term extension studies: 6 months (NCT02871297) followed by another 18 months (NCT03108625). Key safety measures included adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS); effectiveness measures included depression sym

SUBMITTER: DelBello MP 

PROVIDER: S-EPMC12000202 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature