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NCT02372799 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
473
Enrollment target

NCT02372799: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT02372799 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 473 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02372799, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
473 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.

Primary Outcome

The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

Interventions

  • DRUG Placebo
  • DRUG Fluoxetine
  • DRUG Vilazodone

Trial Details

FieldValue
Enrollment Target 473 participants
Start Date 2015-02-28
Est. Completion 2018-09-11
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT02372799 record still lists

NCT02372799 is an interventional study that assigns participants to a tested intervention. The registered 473 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 (39% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02372799 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02372799 about?

NCT02372799 is a clinical study titled "Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)". The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.

What is the current status of trial NCT02372799?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 473 participants. The study started on 2015-02-28. Estimated completion is 2018-09-11.

What interventions are being tested in trial NCT02372799?

The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG), Vilazodone (DRUG).

Who is sponsoring clinical trial NCT02372799?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02372799's enrollment target sits among peer trials

473 811th of 2000 higher than 1,190 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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Source: ClinicalTrials.gov NCT02372799, the US trial registry maintained by the National Library of Medicine. NCT02372799 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.