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NCT02871297 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Terminated
- Registry status
- Phase 3
- Development phase
- 662
- Enrollment target
NCT02871297: Clinical Trial Phase 3 study, sponsored by H. Lundbeck A/S.
NCT02871297 is a Phase 3 study that was terminated before completion, run by H. Lundbeck A/S. The registered enrollment target is 662 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02871297, a Phase 3 study, was terminated before completion, sponsored by H. Lundbeck A/S.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 662 participants
- Enrollment target
Study 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.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and r
Interventions
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2016-08-17 |
| Est. Completion | 2022-04-19 |
| Phase | Phase 3 |
Why NCT02871297 stopped before completion
NCT02871297 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 1 intervention - of which Vortioxetine is the first listed.
NCT02871297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02871297 about?
NCT02871297 is a clinical study titled "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". 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.
What is the current status of trial NCT02871297?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 662 participants. The study started on 2016-08-17. Estimated completion is 2022-04-19.
What interventions are being tested in trial NCT02871297?
The interventions under investigation include: Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT02871297?
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 NCT02871297's enrollment target sits among peer trials
662 554th of 2000 higher than 1,445 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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