Last updated on January 2019

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


Brief description of study

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.

Detailed Study Description

Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:

  • 1-week screening/washout period
  • 8-week double-blind treatment period
  • 1-week double-blind down-taper period

Patients who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

Clinical Study Identifier: NCT02431806

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Noesis Pharma
Phoenix, AZ United States
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University of Arizona Department of Psychiatry
Tucson, AZ United States
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Arkansas Psychiatric Clinic Clinical Research Trials, PA
Little Rock, AR United States
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Searcy Medical Center
Searcy, AR United States
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Woodland Research Northwest, LLC
Springdale, AR United States
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California Pharmaceutical Research Institute, Inc.
Anaheim, CA United States
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Advanced Research Center
Anaheim, CA United States
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CMB Clinical Trials
Colton, CA United States
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Culver City, CA United States
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Sun Valley Research Center
Imperial, CA United States
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Irvine Center for Clinical Research
Irvine, CA United States
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Advanced Research Center, Inc.
La Palma, CA United States
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Alliance for Research
Long Beach, CA United States
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Renew Behavorial Health
Long Beach, CA United States
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Asclepes Research Centers
Panorama City, CA United States
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CITrials - Riverside
Riverside, CA United States
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Langley Porter Psychiatric Institute
San Francisco, CA United States
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Santa Ana, CA United States
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Pacific Clinical Research Medical Group
Upland, CA United States
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MCB Clinical Research Center
Colorado Springs, CO United States
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Comprehensive Psychiatric Care
Norwich, CT United States
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Florida Clinical Research Center; LLC
Bradenton, FL United States
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Fernandina Beach, FL United States
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Gulfcoast Clinical Research Center
Fort Myers, FL United States
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Research in Miami Inc
Hialeah, FL United States
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Advanced Research Institute of Miami
Homestead, FL United States
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George M. Joseph MD, PA d.b.a. JosephCare
Jacksonville Beach, FL United States
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Clinical Neuroscience Solutions, Inc.
Jacksonville, FL United States
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Brevard Clinical Research Center
Melbourne, FL United States
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Clinical Neuroscience Solutions, Inc.
Orlando, FL United States
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Combined Research Orlando Phase I-IV
Orlando, FL United States
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Chicago SBMI Research Center
Panama City, FL United States
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SCORE Physician Alliance, LLC
Saint Petersburg, FL United States
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Medical Research Group of Central Florida
Sanford, FL United States
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Olympian Clinical Research
Tampa, FL United States
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University of South Florida Rothman Center of Neuropsychiatry
Tampa, FL United States
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University of South Florida Board of Trustee
Tampa, FL United States
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Atlanta Center for Medical Research
Atlanta, GA United States
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Institue for Behavioral Medicine
Smyrna, GA United States
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Clinical Research Institute
Stockbridge, GA United States
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Capstone Clinical Research
Libertyville, IL United States
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Sandeep Gaonkar, MD
Naperville, IL United States
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Global Research Holdings, LLC/ NeuroMedical Institute
Vernon Hills, IL United States
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Kentucky Pediatric/ Adult Research
Bardstown, KY United States
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University of Louisville Research Foundation, Inc
Louisville, KY United States
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Adams Clinical Trials, LLC
Watertown, MA United States
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NeuroBehavioral Medicine Group
Bloomfield, MI United States
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Mayo Clinic Depression Center
Rochester, MN United States
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Premier Psychiatric Research Institute, LLC
Lincoln, NE United States
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Kolade Research Institute
Las Vegas, NV United States
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PRA Health Sciences
Marlton, NJ United States
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Princeton Medical Institute
Princeton, NJ United States
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Dent Neurologic Institute
Amherst, NY United States
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Manhattan Behavioral Medicine
New York, NY United States
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The Medical Research Network, LLC
New York, NY United States
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Wake Forest Baptist Health
Winston-Salem, NC United States
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Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
Avon Lake, OH United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Cleveland, OH United States
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Cleveland, OH United States
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Dayton, OH United States
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Investigative Site 015
Garfield Heights, OH United States
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Professional Psychiatric Services
Mason, OH United States
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IPS Research Company
Oklahoma City, OK United States
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Sooner Clinical Research
Oklahoma City, OK United States
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Oklahoma City, OK United States
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Oklahoma City, OK United States
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Tulsa, OK United States
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Cyn3rgy Research
Gresham, OR United States
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Summit Research Network Oregon, Inc.
Portland, OR United States
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Oregon Center for Clinical Investigations, Inc.
Salem, OR United States
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Charleston Pediatrics
Charleston, SC United States
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Clinical Neuroscience Solutions
Memphis, TN United States
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Vanderbilt University Medical Center
Nashville, TN United States
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UTHSC-Houston
Houston, TX United States
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Bay Area Clinical Services dba Earle Research
Houston, TX United States
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Red Oak Psychiatry Associates
Houston, TX United States
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Family Psychiatry of The Woodlands
The Woodlands, TX United States
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UVA Child and Family Psychiatry Clinic
Charlottesville, VA United States
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Clinical Research Partners, LLC
Petersburg, VA United States
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Richmond, VA United States
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Carilion Medical Center
Roanoke, VA United States
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Bellevue, WA United States
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Seattle, WA United States
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San Juan, Puerto Rico
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Michel Woodbury Farina, MD
San Juan, Puerto Rico
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Barbara Diaz-Hernandez MD Research Inc.
San Juan, Puerto Rico
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Harmonex, Inc
Dothan, AL United States
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North Miami, FL United States
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Eastside Therapeutic Resource dba Core Clinical
Everett, WA United States
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Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, NH United States
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Recruitment Status: Open


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