Vortioxetine to Prevent Return of Symptoms in Children With Depression

Depression Clinical Trial

Official title: A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder

Status Terminated

Clinical Trial Summary

The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.

Clinical Trial Description

The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.

The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT05014919
• Study type: Interventional
• Source: H. Lundbeck A/S
• Status: Terminated
• Phase: Phase 3
• Start date: August 10, 2021
• Completion date: April 28, 2022