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NCT03569475 · ClinicalTrials.gov registry record · Phase 3

Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

A Phase 3 study of Major Depressive Disorder, sponsored by Allergan.

Completed
Registry status
Phase 3
Development phase
501
Enrollment target
20
Study locations

NCT03569475 is a Phase 3 study of Major Depressive Disorder that has completed, run by Allergan. The registered enrollment target is 501 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03569475, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 3
Development phase
501 participants
Enrollment target
20
Study locations

Study Summary

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

Conditions Studied

Major Depressive Disorder

Interventions

  • DRUG Placebo
  • DRUG Fluoxetine
  • DRUG Levomilnacipran ER

Study Locations (20)

California

  • Care Access Research, Beverly Hills - Beverly Hills
  • Kindred Medical Institute for Clinical Trials, LLC - Corona
  • Behavioral Research Specialists, LLC - Glendale
  • Sun Valley Research Center - Imperial
  • Alliance Research - Long Beach
  • Excell Research, Inc. - Oceanside
  • NRC Research Institute - Orange
  • Elite Clinical Trials, Inc. - Wildomar

Florida

  • Advanced Research Institute of Miami - Homestead
  • Clinical Neuroscience Solutions, Inc - Jacksonville
  • Zynak Clinical - Lauderdale Lakes
  • Columbus Clinical Services, LLC - Miami
  • Clinical Neuroscience Solutions, Inc. - Orlando

Georgia

  • Atlanta Center for Medical Research - Atlanta
  • Atlanta Behavioral Research, LLC - Atlanta
  • iResearch Atlanta - Decatur
  • Attalla Consultants, LLC - Smyrna
  • Clinical Research Institute - Stockbridge

Arkansas

  • Woodland International Research Group - Little Rock

District of Columbia

  • Children's National Health System - Washington D.C.

Trial Details

FieldValue
Enrollment Target 501 participants
Start Date 2018-07-06
Est. Completion 2021-03-01
Phase Phase 3

Sponsor

Allergan

314 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03569475

The ClinicalTrials.gov registry entry for NCT03569475 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (34% higher). The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03569475 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT03569475 about?

NCT03569475 is a clinical study titled "Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder". The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

What is the current status of trial NCT03569475?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2018-07-06. Estimated completion is 2021-03-01.

What conditions does trial NCT03569475 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT03569475?

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

Who is sponsoring clinical trial NCT03569475?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03569475 being conducted?

This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.