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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: Completed Phase 3 study, sponsored by H. Lundbeck A/S.
NCT02709746 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 784 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (
Interventions
- OTHER Placebo
- DRUG Vortioxetine 10 mg/day
- DRUG Vortioxetine 20 mg/day
- DRUG Fluoxetine 20 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 784 participants |
| Start Date | 2016-05 |
| Est. Completion | 2019-07-30 |
| Phase | Phase 3 |
What the finished NCT02709746 record still lists
NCT02709746 is an interventional study that assigns participants to a tested intervention. The registered 784 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02709746 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02709746's enrollment target sits among peer trials
784 433rd of 2000 higher than 1,568 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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