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

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ClinicalTrials.gov Identifier: NCT02431806
Recruitment Status : Recruiting
First Posted : May 1, 2015
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Levomilnacipran ER Drug: Fluoxetine Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2015
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily orally during the double-blind treatment period.
Drug: Placebo
Experimental: Levomilnacipran ER 40 mg
Patients randomized to the levomilnacipran ER 40 mg arm will take over-encapsulated levomilnacipran ER 40 mg capsules once daily orally during the double-blind treatment period.
Drug: Levomilnacipran ER
Other Name: Fetzima

Experimental: Levomilnacipran ER 80 mg
Patients randomized to the levomilnacipran ER 80 mg arm will take two over-encapsulated levomilnacipran ER 40 mg capsules once daily orally during the double-blind treatment period.
Drug: Levomilnacipran ER
Other Name: Fetzima

Active Comparator: Fluoxetine 20 mg
Patients randomized to the fluoxetine 20 mg arm will take over-encapsulated fluoxetine 20 mg tablets once daily orally during the double-blind treatment period.
Drug: Fluoxetine
Other Name: Prozac




Primary Outcome Measures :
  1. Change in Children's Depression Rating Scale-Revised (CDRS-R) total score [ Time Frame: From Baseline to end of Week 8 ]
    The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years and contains 17 items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression.


Secondary Outcome Measures :
  1. Change in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: From Baseline to end of Week 8 ]
    The CGI-S is a clinician-rated scale used to rate the severity of the patient's current state of mental illness compared with an MDD patient population. The patient will be rated on a scale from 1 to 7, with 1 indicating "normal, not at all ill" and 7 indicating "among the most extremely ill patients."



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female outpatients;12-17 years of age
  2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD) , confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
  3. Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  4. Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
  5. Reliable caregiver
  6. Physical examination, vital signs, clinical laboratory tests, and ECG normal or not clinically significant

Key Psychiatric Exclusion Criteria:

  1. DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
  2. Mental retardation or amnestic or other cognitive disorders

    • 3) Significant suicide risk:
    • Suicide attempt within the past year OR
    • Investigator judgment (based on psychiatric interview and C-SSRS)

Key Treatment-Related Exclusion Criteria:

  1. Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
  2. Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

  1. Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety
  2. Liver enzyme tests (aspartate aminotransferase) AST and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
  3. Clinically significant cardiovascular disorders
  4. Seizure disorder or risk of seizure
  5. Drug or alcohol abuse or dependence (within the past year)
  6. Positive urine drug screen or blood alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431806


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

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Locations
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United States, Alabama
Harmonex, Inc Recruiting
Dothan, Alabama, United States, 36303
United States, Arizona
Noesis Pharma Withdrawn
Phoenix, Arizona, United States, 85032
University of Arizona Department of Psychiatry Recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Psychiatric Clinic Clinical Research Trials, PA Withdrawn
Little Rock, Arkansas, United States, 72211
Searcy Medical Center Withdrawn
Searcy, Arkansas, United States, 72143
Woodland Research Northwest, LLC Withdrawn
Springdale, Arkansas, United States, 72764
United States, California
California Pharmaceutical Research Institute, Inc. Withdrawn
Anaheim, California, United States, 92804
Advanced Research Center Withdrawn
Anaheim, California, United States, 92805
CMB Clinical Trials Withdrawn
Colton, California, United States, 92324
ProScience Research Group Active, not recruiting
Culver City, California, United States, 90230
Sun Valley Research Center Recruiting
Imperial, California, United States, 92251
Irvine Center for Clinical Research Withdrawn
Irvine, California, United States, 92618
Advanced Research Center, Inc. Recruiting
La Palma, California, United States, 90623
Alliance for Research Recruiting
Long Beach, California, United States, 90807
Renew Behavorial Health Withdrawn
Long Beach, California, United States, 90807
Asclepes Research Centers Active, not recruiting
Panorama City, California, United States, 91402
CITrials - Riverside Withdrawn
Riverside, California, United States, 92506
Langley Porter Psychiatric Institute Withdrawn
San Francisco, California, United States, 94143
Syrentis Clinical Research Recruiting
Santa Ana, California, United States, 97025
Pacific Clinical Research Medical Group Active, not recruiting
Upland, California, United States, 91786
United States, Colorado
MCB Clinical Research Center Recruiting
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Comprehensive Psychiatric Care Withdrawn
Norwich, Connecticut, United States, 06360
United States, Florida
Florida Clinical Research Center; LLC Recruiting
Bradenton, Florida, United States, 34201
Coastal Clinical Research Specialists Recruiting
Fernandina Beach, Florida, United States, 32034
Gulfcoast Clinical Research Center Recruiting
Fort Myers, Florida, United States, 33912
Research in Miami Inc Recruiting
Hialeah, Florida, United States, 33013
Advanced Research Institute of Miami Recruiting
Homestead, Florida, United States, 33030
George M. Joseph MD, PA d.b.a. JosephCare Withdrawn
Jacksonville Beach, Florida, United States, 32250
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Brevard Clinical Research Center Withdrawn
Melbourne, Florida, United States, 32904
Innovative Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33161
Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32801
Combined Research Orlando Phase I-IV Withdrawn
Orlando, Florida, United States, 32803
Chicago SBMI Research Center Withdrawn
Panama City, Florida, United States, 32803
SCORE Physician Alliance, LLC Withdrawn
Saint Petersburg, Florida, United States, 33710
Medical Research Group of Central Florida Recruiting
Sanford, Florida, United States, 32771
Olympian Clinical Research Withdrawn
Tampa, Florida, United States, 33609
University of South Florida Rothman Center of Neuropsychiatry Withdrawn
Tampa, Florida, United States, 33612
University of South Florida Board of Trustee Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Institue for Behavioral Medicine Recruiting
Smyrna, Georgia, United States, 30080
Clinical Research Institute Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Capstone Clinical Research Withdrawn
Libertyville, Illinois, United States, 60048
Sandeep Gaonkar, MD Recruiting
Naperville, Illinois, United States, 60563
Global Research Holdings, LLC/ NeuroMedical Institute Recruiting
Vernon Hills, Illinois, United States, 60061
United States, Kentucky
Kentucky Pediatric/ Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
University of Louisville Research Foundation, Inc Withdrawn
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Adams Clinical Trials, LLC Recruiting
Watertown, Massachusetts, United States, 02472
United States, Michigan
NeuroBehavioral Medicine Group Withdrawn
Bloomfield, Michigan, United States, 48302
United States, Minnesota
Mayo Clinic Depression Center Withdrawn
Rochester, Minnesota, United States, 55905
United States, Nebraska
Premier Psychiatric Research Institute, LLC Recruiting
Lincoln, Nebraska, United States, 68526
United States, Nevada
Kolade Research Institute Active, not recruiting
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Healthy Perspectives - Innovative Mental Health Services. PLLC Active, not recruiting
Nashua, New Hampshire, United States, 03060
United States, New Jersey
PRA Health Sciences Withdrawn
Marlton, New Jersey, United States, 08053
Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Dent Neurologic Institute Withdrawn
Amherst, New York, United States, 14226
Manhattan Behavioral Medicine Recruiting
New York, New York, United States, 10022
The Medical Research Network, LLC Withdrawn
New York, New York, United States, 10128
United States, North Carolina
Wake Forest Baptist Health Withdrawn
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC Withdrawn
Avon Lake, Ohio, United States, 44012
Cincinnati Children's Hospital Medical Center Withdrawn
Cincinnati, Ohio, United States, 45255
University Hospitals Case Medical Center Withdrawn
Cleveland, Ohio, United States, 44106
The Cleveland Clinic Foundation Withdrawn
Cleveland, Ohio, United States, 44195
Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
Investigative Site 015 Withdrawn
Garfield Heights, Ohio, United States, 44125
Professional Psychiatric Services Recruiting
Mason, Ohio, United States, 45040
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
Sooner Clinical Research Recruiting
Oklahoma City, Oklahoma, United States, 73112
Cutting Edge Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73116
Paradigm Research Professionals Recruiting
Oklahoma City, Oklahoma, United States, 73118
Tulsa Clinical Research, LLC Active, not recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Cyn3rgy Research Withdrawn
Gresham, Oregon, United States, 97030
Summit Research Network Oregon, Inc. Withdrawn
Portland, Oregon, United States, 97210
Oregon Center for Clinical Investigations, Inc. Recruiting
Salem, Oregon, United States, 97301
United States, South Carolina
Charleston Pediatrics Withdrawn
Charleston, South Carolina, United States, 29403
United States, Tennessee
Clinical Neuroscience Solutions Withdrawn
Memphis, Tennessee, United States, 38119
Vanderbilt University Medical Center Withdrawn
Nashville, Tennessee, United States, 37212
United States, Texas
UTHSC-Houston Recruiting
Houston, Texas, United States, 77054
Bay Area Clinical Services dba Earle Research Recruiting
Houston, Texas, United States, 77058
Red Oak Psychiatry Associates Recruiting
Houston, Texas, United States, 77090
Family Psychiatry of The Woodlands Recruiting
The Woodlands, Texas, United States, 77381
United States, Virginia
UVA Child and Family Psychiatry Clinic Recruiting
Charlottesville, Virginia, United States, 22903
Clinical Research Partners, LLC Withdrawn
Petersburg, Virginia, United States, 23805
Alliance Research Group Withdrawn
Richmond, Virginia, United States, 23230
Carilion Medical Center Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Eastside Therapeutic Resource dba Core Clinical Recruiting
Everett, Washington, United States, 98201
Summit Research Network Seattle Withdrawn
Seattle, Washington, United States, 98104
Puerto Rico
INSPIRA Clinical Research Recruiting
San Juan, Puerto Rico, 00918
Michel Woodbury Farina, MD Withdrawn
San Juan, Puerto Rico, 00919-2133
Barbara Diaz-Hernandez MD Research Inc. Withdrawn
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Daniel Radecki Forest Research Institute, Inc., an affiliate of Allergan, plc

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02431806     History of Changes
Obsolete Identifiers: NCT03087916
Other Study ID Numbers: LVM-MD-11
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Fluoxetine
Levomilnacipran
Milnacipran
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents