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Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

NCT02709746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2020-08-19

Study results available
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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).

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Vortioxetine 10 mg/day

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

DRUG

Vortioxetine 20 mg/day

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

DRUG

Fluoxetine 20 mg/day

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

OTHER

Placebo

Encapsulated tablet

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-07-02
Completion
2019-07-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Colombia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT02709746 on ClinicalTrials.gov