CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 683 enrolled
Drug / intervention
Vortioxetine 10 mg/day +3 moredrug
Likely dose
Vortioxetine 10 mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02709655
NCT02709655Phase 3Completed
CompareCT.gov

Interventional, Randomized, Double-blind, Placebo-controlled, Active-reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years, With Major Depressive Disorder (MDD)

H. Lundbeck A/S·interventional·Posted Mar 16, 2016·Updated Sep 22, 2022

In Brief

A Phase 3 clinical trial evaluating Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, and 2 other interventions for Depressive Disorder, Major. Completed, enrolled 683 participants across 98 sites in 19 countries.

Detailed Summary

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesBulgaria, Canada, Colombia, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Mexico, Poland, Russia, Serbia, South Africa, South Korea, Spain, Ukraine, United States
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartMay 18, 2016
Primary CompletionJan 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.3 years ago

Interventions

Vortioxetine 10 mg/daydrug

10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed

Vortioxetine 20 mg/daydrug

20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed

Fluoxetine 20mg/daydrug

20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed

Placeboother

Encapsulated tablet, orally