Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
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
1 other identifier
interventional
501
1 country
51
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).
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 Jul 2018
Typical duration for phase_3 major-depressive-disorder
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedResults Posted
Study results publicly available
March 25, 2022
CompletedMarch 25, 2022
March 1, 2022
2.7 years
June 15, 2018
March 1, 2022
March 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R)
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the 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 (3)
Levomilnacipran ER 40-80 mg/day
EXPERIMENTALLevomilnacipran extended release (ER) capsules, orally, 10 milligram per day (mg/day) on Days 1 to 3, 20 mg/day on Days 4 to 7, and 40 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by levomilnacipran ER 40 mg/day on Days 1 and 2, and then 20 mg/day from Day 3 through Day 7 in the Down-taper Period. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day was permitted at Week 3 of the Double-blind Treatment Period.
Fluoxetine 20 mg/day
ACTIVE COMPARATORFluoxetine capsule, orally, 10 mg/day at Week 1, and 20 mg/day from Week 2 through Week 8 of the Double-blind Treatment Period followed by fluoxetine 10 mg/day from Day 1 through Day 7 of the Down-taper Period.
Placebo
PLACEBO COMPARATORMatching placebo capsules once daily through 8 weeks in the Double-blind Treatment Period and Days 1 through 7 in the Down-taper Period.
Interventions
Eligibility Criteria
You may qualify if:
- 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 patients 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 patients 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.
You may not qualify if:
- 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 patients 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (51)
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Care Access Research, Beverly Hills
Beverly Hills, California, 90212, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Alliance Research
Long Beach, California, 90807, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
NRC Research Institute
Orange, California, 92868, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Children's National Health System
Washington D.C., District of Columbia, 20910, United States
Advanced Research Institute of Miami
Homestead, Florida, 33030, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Zynak Clinical
Lauderdale Lakes, Florida, 33313, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Attalla Consultants, LLC
Smyrna, Georgia, 30082, United States
Clinical Research Institute
Stockbridge, Georgia, 30281, United States
Inova Clinical trials and Research Center
Tyrone, Georgia, 30290, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR Conventions Limited
Naperville, Illinois, 60563, United States
AMR-Baber Research, Inc.
Naperville, Illinois, 60563, United States
KU Wichita Clinical Trial Unit
Wichita, Kansas, 67214, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70629, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
Millennium Center for Clinical Research
Creve Coeur, Missouri, 63141, United States
Millennium Psychiatric Associates, LLC
St Louis, Missouri, 63132, United States
Alivation Research
Lincoln, Nebraska, 68526, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036, United States
Finger Lake Clinical Research
Rochester, New York, 14618-1609, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
The Ohio State University Department of Psychiatry
Columbus, Ohio, 43210, United States
Professional Psychiatric Services
Mason, Ohio, 45040, United States
CincyScience
West Chester, Ohio, 45069, United States
IPS Research
Oklahoma City, Oklahoma, 73106, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
Houston Clinical Trials, LLC
Bellaire, Texas, 77401, United States
Roque Medical Trails LLC
Dallas, Texas, 75243, United States
El Campo Clinical Trials
El Campo, Texas, 77437, United States
Mech Healthcare Associates
Frisco, Texas, 75034, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Northpointe Psychiatry
Lewisville, Texas, 75057, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069, United States
AIM Trials
Plano, Texas, 75093, United States
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
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
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
Daniel Radecki, PhD
Allergan
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
June 15, 2018
First Posted
June 26, 2018
Study Start
July 6, 2018
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
March 25, 2022
Results First Posted
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.