Clinical Trials Directory

Trials / Completed

CompletedNCT03108625

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
94 (actual)
Sponsor
H. Lundbeck A/S · Industry
Sex
All
Age
7 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGVortioxetineTarget dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.

Timeline

Start date
2017-03-01
Primary completion
2020-04-16
Completion
2020-04-16
First posted
2017-04-11
Last updated
2021-06-24

Locations

31 sites across 13 countries: Bulgaria, Estonia, France, Germany, Hungary, Italy, Latvia, Poland, Russia, Serbia, South Africa, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT03108625. Inclusion in this directory is not an endorsement.

Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years (NCT03108625) · Clinical Trials Directory