NCT02871297

Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Vortioxetine	Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.

Timeline

• Start date: 2016-08-17
• Primary completion: 2022-03-25
• Completion: 2022-04-19
• First posted: 2016-08-18
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

78 sites across 20 countries: United States, Bulgaria, Canada, Colombia, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Mexico, Poland, Russia, Serbia, South Africa, South Korea, Spain, Ukraine, United Kingdom