Vortioxetine for Major Depressive Disorder in Children: 12-Week Randomized, Placebo-Controlled Study.

ABSTRACT:

Objective

To evaluate efficacy, safety, and tolerability of vortioxetine in children ages 7 to 11 years with major depressive disorder.

Method

Patients meeting criteria for incomplete improvement in depressive symptoms (Children's Depression Rating Scale-Revised [CDRS-R] total score ≥40 plus <40% reduction and Parent Global Assessment Global Improvement score >2) after 4 weeks of single-blind lead-in treatment with a brief psychosocial intervention plus placebo were randomized 1:1:1:1 to 8-week double-blind treatment with brief psychosocial intervention and placebo, vortioxetine 10 mg/day, vortioxetine 20 mg/day, or fluoxetine 20 mg/day. Following preplanned interim analysis, enrollment to fluoxetine was stopped, and patients were randomized 1:1:1 to placebo, vortioxetine 10

SUBMITTER: Huss M 

PROVIDER: S-EPMC12414324 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature