NCT05014919

Vortioxetine to Prevent Return of Symptoms in Children With Depression

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Vortioxetine	Tablets
DRUG	Placebo	Tablets

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-03-31
• Completion: 2022-04-28
• First posted: 2021-08-20
• Last updated: 2023-01-05
• Results posted: 2023-01-05

Locations

17 sites across 7 countries: United States, Colombia, Latvia, Mexico, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study