Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
1 other identifier
interventional
552
2 countries
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Started Jun 2015
Longer than P75 for phase_3 major-depressive-disorder
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedStudy Start
First participant enrolled
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2019
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedSeptember 7, 2020
August 1, 2020
4.2 years
April 28, 2015
August 19, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Baseline (Week 0) to Week 8
Secondary Outcomes (1)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Baseline (Week 0) to Week 8
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Levomilnacipran 40 mg
EXPERIMENTALParticipants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Levomilnacipran 80 mg
EXPERIMENTALParticipants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Fluoxetine 20 mg
ACTIVE COMPARATORParticipants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Interventions
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
Eligibility Criteria
You may qualify if:
- Male or female outpatients;12-17 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
- Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
- Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
- Reliable caregiver
- Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant
You may not qualify if:
- DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
- Mental retardation or amnestic or other cognitive disorders
- Significant suicide risk:
- Suicide attempt within the past year OR
- Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))
- Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
- Use of prohibited concomitant medication that cannot be discontinued
- Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
- Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2X the upper limit of normal (ULN)
- Clinically significant cardiovascular disorders
- Seizure disorder or risk of seizure
- Drug or alcohol abuse or dependence (within the past year)
- Positive urine drug screen or blood alcohol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Harmonex, Inc
Dothan, Alabama, 36303, United States
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724, United States
Advanced Research Center, Inc.
Anaheim, California, 92801, United States
ProScience Research Group
Culver City, California, 90230, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Alliance for Research
Long Beach, California, 90807, United States
Asclepes Research Centers
Panorama City, California, 91402, United States
Syrentis Clinical Research
Santa Ana, California, 97025, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
MCB Clinical Research Center
Colorado Springs, Colorado, 80910, United States
Florida Clinical Research Center; LLC
Bradenton, Florida, 34201, United States
Coastal Clinical Research Specialists
Fernandina Beach, Florida, 32034, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Research in Miami Inc
Hialeah, Florida, 33013, United States
Advanced Research Institute of Miami
Homestead, Florida, 33030, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
University of South Florida Board of Trustee
Tampa, Florida, 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Institute for Behavioral Medicine
Smyrna, Georgia, 30080-2620, United States
Clinical Research Institute
Stockbridge, Georgia, 30281, United States
Sandeep Gaonkar, MD
Naperville, Illinois, 60563, United States
NeuroMedical Institute
Panama, Illinois, 32405, United States
Kentucky Pediatric Research
Bardstown, Kentucky, 40004, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts, 02472, United States
Alivation Research
Lincoln, Nebraska, 68526, United States
Kolade Research Institute
Las Vegas, Nevada, 89102, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire, 03060, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
UTHSC-Houston
Houston, Texas, 77054, United States
Bay Area Clinical Services dba Earle Research
Houston, Texas, 77058, United States
Red Oak Psychiatry Associates
Houston, Texas, 77090, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
UVA Child and Family Psychiatry Clinic
Charlottesville, Virginia, 22903, United States
Carilion Medical Center
Roanoke, Virginia, 24014, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Eastside Therapeutic Resource dba Core Clinical
Everett, Washington, 98201, United States
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico
Related Publications (1)
Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, Aziz M. Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies. J Child Adolesc Psychopharmacol. 2024 Jun;34(5):241-250. doi: 10.1089/cap.2023.0080. Epub 2024 May 3.
PMID: 38700708DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Daniel Radecki
Forest Research Institute, Inc., an affiliate of Allergan, plc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 1, 2015
Study Start
June 23, 2015
Primary Completion
August 19, 2019
Study Completion
August 19, 2019
Last Updated
September 7, 2020
Results First Posted
September 7, 2020
Record last verified: 2020-08