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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

NCT02871297 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 662

Last updated 2022-12-28

Study results available
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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

DRUG

Vortioxetine

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2022-03-25
Completion
2022-04-19

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871297 on ClinicalTrials.gov