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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431806
• Other study ID #: LVM-MD-11
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2015
• Est. completion date: August 19, 2019

Study information

• Verified date: August 2020
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Participants 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.

Other known NCT identifiers

• NCT03087916

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Key Inclusion Criteria:

• 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

Key Psychiatric Exclusion Criteria:

• 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))

Key Treatment-Related Exclusion Criteria:

• 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

Other Key Medical Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Placebo
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
• Levomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
• Fluoxetine
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.

Locations

Country	Name	City	State
Puerto Rico	INSPIRA Clinical Research	San Juan
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Kentucky Pediatric Research	Bardstown	Kentucky
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center; LLC	Bradenton	Florida
United States	UVA Child and Family Psychiatry Clinic	Charlottesville	Virginia
United States	MCB Clinical Research Center	Colorado Springs	Colorado
United States	ProScience Research Group	Culver City	California
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Harmonex, Inc	Dothan	Alabama
United States	Eastside Therapeutic Resource dba Core Clinical	Everett	Washington
United States	Coastal Clinical Research Specialists	Fernandina Beach	Florida
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Research in Miami Inc	Hialeah	Florida
United States	Advanced Research Institute of Miami	Homestead	Florida
United States	Bay Area Clinical Services dba Earle Research	Houston	Texas
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	UTHSC-Houston	Houston	Texas
United States	Sun Valley Research Center	Imperial	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Kolade Research Institute	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Alivation Research	Lincoln	Nebraska
United States	Alliance for Research	Long Beach	California
United States	Professional Psychiatric Services	Mason	Ohio
United States	Sandeep Gaonkar, MD	Naperville	Illinois
United States	Healthy Perspectives - Innovative Mental Health Services. PLLC	Nashua	New Hampshire
United States	Manhattan Behavioral Medicine	New York	New York
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Paradigm Research Professionals	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	NeuroMedical Institute	Panama City	Illinois
United States	Asclepes Research Centers	Panorama City	California
United States	Princeton Medical Institute	Princeton	New Jersey
United States	Carilion Medical Center	Roanoke	Virginia
United States	Oregon Center for Clinical Investigations, Inc.	Salem	Oregon
United States	Syrentis Clinical Research	Santa Ana	California
United States	Institute for Behavioral Medicine	Smyrna	Georgia
United States	Clinical Research Institute	Stockbridge	Georgia
United States	University of South Florida Board of Trustee	Tampa	Florida
United States	Family Psychiatry of The Woodlands	The Woodlands	Texas
United States	University of Arizona Department of Psychiatry	Tucson	Arizona
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.	Baseline (Week 0) to Week 8