Clinical trial NCT02431806: Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2015-05-01
Enrollment: 552
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
timeFrame: Baseline (Week 0) to Week 8
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
timeFrame: Baseline (Week 0) to Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex, Inc
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Department of Psychiatry
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Long Beach
country: United States
facility: Alliance for Research
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Center
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center; LLC
state: Florida
city: Fernandina Beach
country: United States
facility: Coastal Clinical Research Specialists
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hialeah
country: United States
facility: Research in Miami Inc
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida Board of Trustee
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Naperville
country: United States
facility: Sandeep Gaonkar, MD
state: Illinois
city: Panama City
country: United States
facility: NeuroMedical Institute
state: Illinois
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: Las Vegas
country: United States
facility: Kolade Research Institute
state: Nevada
city: Nashua
country: United States
facility: Healthy Perspectives - Innovative Mental Health Services. PLLC
state: New Hampshire
city: Princeton
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Houston
country: United States
facility: UTHSC-Houston
state: Texas
city: Houston
country: United States
facility: Bay Area Clinical Services dba Earle Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: Charlottesville
country: United States
facility: UVA Child and Family Psychiatry Clinic
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Eastside Therapeutic Resource dba Core Clinical
state: Washington
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research
Study officials:
affiliation: Forest Research Institute, Inc., an affiliate of Allergan, plc
name: Daniel Radecki
role: STUDY_DIRECTOR
References: