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

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ClinicalTrials.gov Identifier: NCT03569475
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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)

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 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 Pediatric Patients 7-17 Years With Major Depressive Disorder
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : May 19, 2021
Estimated Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levomilnacipran ER
patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during weeks 2 through 8 of the double blinded treatment and 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days in the down-taper period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3 through 8 of the double blinded treatment. in the down-taper period. the patient will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days
Drug: Levomilnacipran ER
During the double-blind treatment period, patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during Weeks 2 through 8. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3. During the down-taper period, patients will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days

Active Comparator: Fluoxetine 20 mg
Patients randomized to the Fluoxetine 20 mg arm will take Week 1, 10mg/day; week 2 through week 8, 20 mg/day
Drug: Fluoxetine
During the double-blind treatment period, patients will take Fluoxetine 10 mg/day on Days 1-7, and then 20 mg/day during Weeks 2 through Week 8. During the down-taper period, patients will take Fluoxetine 10 mg/day for 7 days.

Placebo Comparator: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily through week 8
Drug: Placebo
Patients randomized to the placebo arm will take placebo capsules once daily




Primary Outcome Measures :
  1. Change from baseline in Children's Depression Rating Scale- Revised (CDRS-R) [ Time Frame: 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 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113.


Secondary Outcome Measures :
  1. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale [ Time Frame: 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 a "normal, not at all ill" and 7 indicating "among the most extremely ill patients."



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet Diagnostic and statistical manual of mental disorders fifth edition (DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders - Present and Lifetime (K-SADS-PL)
  • Patients must have a score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
  • Patients must have a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
  • Patients must have a caregiver who can and is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of investigational product, and accompany the patient to all study visits
  • Female patients of childbearing potential who are sexually active must agree to use a reliable method of contraception that will continue for the duration of the study and within 30 days following the end of study participation.
  • A sexually active male patient must agree to use contraception as detailed below during the treatment period and for at least 30 days after the last dose of investigational product.

Exclusion Criteria:

  • DSM-5-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment.
  • Prior diagnosis of mental retardation or amnestic or other cognitive disorders based on DSM-5 criteria
  • Imminent risk of injuring self or others or causing damage to property as judged by the Investigator
  • Suicide risk as determined by meeting either of the following criteria:

    • Any suicide attempt within the past year
    • Significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS) treatment-Related Criteria
  • History of allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other Selective serotonin reuptake inhibitors (SSRI) or Serotonin and norepinephrine reuptake inhibitors (SNRI) or known hypersensitivity to the investigational products' non-medicinal ingredients including gelatin and cellulose
  • Patients requiring prohibited concomitant medication or herbal supplements that could not be discontinued or switched to an allowable alternative medication and stabilized for at least 2 weeks preceding Visit 2 (Baseline)
  • Patients taking any psychoactive drug or psychoactive herbal remedy within 5 half-lives before Baseline (Visit 2), Patients who have ever been treated with a depot antipsychotic must also be excluded
  • Patients who have initiated or terminated psychotherapy or behavior therapy within1 month before Visit 1 (Screening), or who plan to initiate or change such therapies during the course of the study Other Medical criteria
  • A clinically significant disease state that, in the investigator's opinion, might indicate that the patient is unsuitable for the study
  • Any cardiovascular disease or condition that is clinically significant, unstable, or decompensated.
  • Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 3 months before Visit 1 (Screening)
  • Any condition that would be expected to affect drug absorption (eg, gastric bypass surgery)
  • History of seizure disorder (except simple childhood febrile seizures before age 5), unexplained syncope or black-out episodes, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes the patient toward a risk for seizure
  • History of drug or alcohol abuse or dependence within the past year
  • Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during the study or within 30 days following the end of study participation

Other Criteria

  • Patients who are unable to swallow capsules
  • Treatment with any investigational product within 3 months (or at least 5 half-lives, whichever is longer) of Visit 1. Treatment with any investigational product other than those provided by AGN during study participation will be a protocol violation, and the patient will be terminated from this study
  • Employee or immediate relative of an employee of AGN, any of its affiliates or partners, or of the study center Patients or patients whose parent/guardian/LAR and/or caregivers are unable to speak and understand English (or their native language if this can be accommodated by the site and is approved by the Sponsor) sufficiently to understand the nature of the study, to provide informed assent/consent, or to allow the completion of all study assessments
  • Unable or unlikely to comply with the study protocol or are unsuitable for any other reason, as judged by the Investigator

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): NCT03569475


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, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Study Coordinator    501-221-8681      
United States, California
Care Access Research, Beverly Hills Recruiting
Beverly Hills, California, United States, 90212
Contact: Study Coordinator    424-281-7249      
Kindred Medical Institute for Clinical Trials, LLC Recruiting
Corona, California, United States, 92879
Contact: Study Coordinator    951-220-4029      
Behavioral Research Specialists, LLC Recruiting
Glendale, California, United States, 91206
Contact: Study Coordinator    888-255-5798      
Alliance Research Recruiting
Long Beach, California, United States, 90807
Contact: Study Coordinator    562-748-4999      
Excell Research, Inc Recruiting
Oceanside, California, United States, 92056
Contact: Study Coordinator    760-758-2222      
Orange County Neuropsychiatric Research Center, LLC Recruiting
Orange, California, United States, 92868
Contact: Study Coordinator    714-289-1100      
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Elite Clinical Trials, Inc. Recruiting
Wildomar, California, United States, 92595
Contact: Study Coordinator    951-678-1551      
United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Study Coordinator    202-476-2088      
United States, Florida
Advanced Research Institute of Miami Recruiting
Homestead, Florida, United States, 33030
Contact: Study Coordinator    305-246-0001      
Clinical Neuroscience Solutions, Inc Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator    904-281-5757      
Zynak Clinical Recruiting
Lauderdale Lakes, Florida, United States, 33313
Contact: Study Coordinator    954-533-3707      
Columbus Clinical Services, LLC Not yet recruiting
Miami, Florida, United States, 33125
Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32801
Contact: Study Coordinator    407-425-5100      
United States, Georgia
Atlanta Behavioral Research, LLC Recruiting
Atlanta, Georgia, United States, 30338
Contact: Study Coordinator    770-458-0447      
iResearch Atlanta, LLC Recruiting
Decatur, Georgia, United States, 30030
Contact: Study Coordinator    404-537-1281      
Attalla Consultants, LLC Recruiting
Smyrna, Georgia, United States, 30082
Contact: Study Coordinator , 770-319-8025         
Clinical Research Institute Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Study Coordinator    770-507-8344      
INOVA clinical trials and research center Recruiting
Tyrone, Georgia, United States, 30290
Contact: Study Coordinator    678-519-3088      
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Contact: Study Coordinator    208-377-8653      
United States, Illinois
Joliet Center Clinical Research Recruiting
Joliet, Illinois, United States, 60435
Contact: Study Coordinator    815-729-7790      
Capstone Clinical Research Recruiting
Libertyville, Illinois, United States, 60048
Contact: Study Coordinator    847-549-7214      
AMR-Baber Research, Inc. Recruiting
Naperville, Illinois, United States, 60563
Contact: Study Coordinator    630-844-2095      
Southern Illinois University School of Medicine Not yet recruiting
Springfield, Illinois, United States, 62702
United States, Kansas
Psychiatric Associates Not yet recruiting
Overland Park, Kansas, United States, 66211
KU Wichita Center for Clinical Research Recruiting
Wichita, Kansas, United States, 67214
Contact: Study Coordinator    316-293-3805      
United States, Louisiana
Lake Charles Clinical Trials, LLC Recruiting
Lake Charles, Louisiana, United States, 70629
Contact: Study Coordinator    337-564-6405      
United States, Maryland
Kennedy Krieger Institute Withdrawn
Baltimore, Maryland, United States, 21205
United States, Michigan
Rochester Center for Behavioral Medicine Recruiting
Rochester Hills, Michigan, United States, 48307
Contact: Study Coordinator    248-608-8800      
United States, Missouri
Millennium Center for Clinical Research Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Study Coordinator    314-298-0001      
United States, New York
Manhattan Behavioral Medicine, PLLC Not yet recruiting
New York, New York, United States, 10036
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Study Coordinator    585-241-9670      
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Study Coordinator    513-558-2931      
The Ohio State University Department of Psychiatry Recruiting
Columbus, Ohio, United States, 43210
Contact: Study Coordinator    614-293-5517      
Professional Psychiatric Services Recruiting
Mason, Ohio, United States, 45040
Contact: Study Coordinator    513-229-7585      
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73106
Contact: Study Coordinator    405-235-8188      
United States, Texas
BioBehavioral Research of Austin Recruiting
Austin, Texas, United States, 78759
Contact: Study Coordinator    512-382-6661      
Houston Clinical Trials Recruiting
Bellaire, Texas, United States, 77401
Contact: Study Coordinator    713-665-8787      
Relaro Medical Trials Recruiting
Dallas, Texas, United States, 75243
Contact: Study Coordinator    469-730-3282      
El Campo Clinical Trials Withdrawn
El Campo, Texas, United States, 77437
Mech Healthcare Associates Terminated
Frisco, Texas, United States, 75034
Biopharma Informatic, LLC Recruiting
Houston, Texas, United States, 77084
Contact: Study Coordinator    281-944-3610      
Red Oak Psychiatry Associates, PA Not yet recruiting
Houston, Texas, United States, 77090
Northpointe Psychiatry Recruiting
Lewisville, Texas, United States, 75057
Contact: Study Coordinator    214-229-9102      
Metroplex Pulmonary and Sleep Center Recruiting
McKinney, Texas, United States, 75069
Contact: Study Coordinator    972-838-1892      
AIM Trials Recruiting
Plano, Texas, United States, 75093
Contact: Study Coordinator    972-241-1222      
Clinical Trials of Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-949-0122      
Family Psychiatry of The Woodlands Not yet recruiting
The Woodlands, Texas, United States, 77381
United States, Utah
Ericksen Research and Development Recruiting
Clinton, Utah, United States, 84015
Contact: Study Coordinator    801-614-5501      
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Contact: Study Coordinator    425-453-0404      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Daniel Radecki, PhD Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03569475     History of Changes
Other Study ID Numbers: LVM-MD-14
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019

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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
Milnacipran
Fluoxetine
Levomilnacipran
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