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NCT02709746 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by H. Lundbeck A/S.

Completed
Registry status
Phase 3
Development phase
784
Enrollment target

NCT02709746 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 784 participants.

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The verdict

NCT02709746, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.

COMPLETED
Registry status
Phase 3
Development phase
784 participants
Enrollment target

Study 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).

Interventions

  • OTHER Placebo
  • DRUG Vortioxetine 10 mg/day
  • DRUG Vortioxetine 20 mg/day
  • DRUG Fluoxetine 20 mg/day

Trial Details

FieldValue
Enrollment Target 784 participants
Start Date 2016-05
Est. Completion 2019-07-30
Phase Phase 3

Sponsor

H. Lundbeck A/S

72 total trials

What the Registry Record Tells You About NCT02709746

The ClinicalTrials.gov registry entry for NCT02709746 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 784 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lundbeck A/S, which has 72 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02709746 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02709746 about?

NCT02709746 is a clinical study titled "Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)". 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).

What is the current status of trial NCT02709746?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 784 participants. The study started on 2016-05. Estimated completion is 2019-07-30.

What interventions are being tested in trial NCT02709746?

The interventions under investigation include: Placebo (OTHER), Vortioxetine 10 mg/day (DRUG), Vortioxetine 20 mg/day (DRUG), Fluoxetine 20 mg/day (DRUG).

Who is sponsoring clinical trial NCT02709746?

This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.