CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 784 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/NCT02709746
NCT02709746Phase 3Completed
CompareCT.gov

Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

H. Lundbeck A/S·interventional·Posted Mar 16, 2016·Updated Aug 19, 2020

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 784 participants across 124 sites in 19 countries.

Detailed Summary

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartMay 1, 2016
Primary CompletionJul 2, 2019
Study CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.3 years ago

Interventions

Vortioxetine 10 mg/daydrug

10 mg/day, encapsulated tablet (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 (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 20 mg/daydrug

20 mg/day, encapsulated tablet (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