Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02709655 · ClinicalTrials.gov registry record · Phase 3
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 683
- Enrollment target
NCT02709655: Completed Phase 3 study, sponsored by H. Lundbeck A/S.
NCT02709655 is a Phase 3 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 683 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02709655, a Phase 3 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 683 participants
- Enrollment target
Study Summary
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
Primary Outcome
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A ra
Interventions
- OTHER Placebo
- DRUG Vortioxetine 10 mg/day
- DRUG Vortioxetine 20 mg/day
- DRUG Fluoxetine 20mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 683 participants |
| Start Date | 2016-05-18 |
| Est. Completion | 2022-01-21 |
| Phase | Phase 3 |
What the finished NCT02709655 record still lists
NCT02709655 is an interventional study that assigns participants to a tested intervention. The registered 683 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 (12% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02709655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02709655 about?
NCT02709655 is a clinical study titled "Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)". Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
What is the current status of trial NCT02709655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 683 participants. The study started on 2016-05-18. Estimated completion is 2022-01-21.
What interventions are being tested in trial NCT02709655?
The interventions under investigation include: Placebo (OTHER), Vortioxetine 10 mg/day (DRUG), Vortioxetine 20 mg/day (DRUG), Fluoxetine 20mg/day (DRUG).
Who is sponsoring clinical trial NCT02709655?
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 NCT02709655's enrollment target sits among peer trials
683 529th of 2000 higher than 1,472 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06795087 · 684 participants
Discharge Medication Use Post-Operatively in GU Cancer Patients
- NCT05099770 · 685 participants · Phase 3
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
- NCT05880199 · 685 participants
BSGM to Evaluate Patients With GI Symptoms
- NCT05382559 · 681 participants · Phase 1
A Study of ASP3082 in Adults With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI