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Completed Phase 3 Interventional Results available

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

ClinicalTrials.gov ID: NCT02431806

Public ClinicalTrials.gov record NCT02431806. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.

Study identification

NCT ID
NCT02431806
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
552 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 23, 2015 (Actual)
Primary completion
Aug 19, 2019 (Actual)
Completion
Aug 19, 2019 (Actual)
Last update posted
Sep 7, 2020

2015 – 2019

United States locations

U.S. sites
48
U.S. states
20
U.S. cities
43
Facility City State ZIP Site status
Harmonex, Inc Dothan Alabama 36303 —
University of Arizona Department of Psychiatry Tucson Arizona 85724 —
Advanced Research Center, Inc. Anaheim California 92801 —
ProScience Research Group Culver City California 90230 —
Sun Valley Research Center Imperial California 92251 —
Alliance for Research Long Beach California 90807 —
Asclepes Research Centers Panorama City California 91402 —
Syrentis Clinical Research Santa Ana California 97025 —
Pacific Clinical Research Medical Group Upland California 91786 —
MCB Clinical Research Center Colorado Springs Colorado 80910 —
Florida Clinical Research Center; LLC Bradenton Florida 34201 —
Coastal Clinical Research Specialists Fernandina Beach Florida 32034 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
Research in Miami Inc Hialeah Florida 33013 —
Advanced Research Institute of Miami Homestead Florida 33030 —
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32256 —
Innovative Clinical Research, Inc. Lauderhill Florida 33319 —
Medical Research Group of Central Florida Orange City Florida 32763 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32801 —
University of South Florida Board of Trustee Tampa Florida 33613 —
Atlanta Center for Medical Research Atlanta Georgia 30331 —
Institute for Behavioral Medicine Smyrna Georgia 30080-2620 —
Clinical Research Institute Stockbridge Georgia 30281 —
Sandeep Gaonkar, MD Naperville Illinois 60563 —
NeuroMedical Institute Panama Illinois 32405 —
Kentucky Pediatric Research Bardstown Kentucky 40004 —
Adams Clinical Trials, LLC Watertown Massachusetts 02472 —
Alivation Research Lincoln Nebraska 68526 —
Kolade Research Institute Las Vegas Nevada 89102 —
Healthy Perspectives - Innovative Mental Health Services. PLLC Nashua New Hampshire 03060 —
Princeton Medical Institute Princeton New Jersey 08540 —
Manhattan Behavioral Medicine New York New York 10036 —
Midwest Clinical Research Center Dayton Ohio 45417 —
Professional Psychiatric Services Mason Ohio 45040 —
IPS Research Company Oklahoma City Oklahoma 73106 —
Sooner Clinical Research Oklahoma City Oklahoma 73112 —
Cutting Edge Research Group Oklahoma City Oklahoma 73116 —
Paradigm Research Professionals Oklahoma City Oklahoma 73118 —
Tulsa Clinical Research, LLC Tulsa Oklahoma 74104 —
Oregon Center for Clinical Investigations, Inc. Salem Oregon 97301 —
UTHSC-Houston Houston Texas 77054 —
Bay Area Clinical Services dba Earle Research Houston Texas 77058 —
Red Oak Psychiatry Associates Houston Texas 77090 —
Family Psychiatry of The Woodlands The Woodlands Texas 77381 —
UVA Child and Family Psychiatry Clinic Charlottesville Virginia 22903 —
Carilion Medical Center Roanoke Virginia 24014 —
Northwest Clinical Research Center Bellevue Washington 98007 —
Eastside Therapeutic Resource dba Core Clinical Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02431806, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2020 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02431806 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →