Clinical trial NCT03569475: Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-06-26
Enrollment: 501
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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 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.

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 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
* 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
* 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 Allergan (AGN), any of its affiliates or partners, or of the study center
* Patients or patients whose parent/guardian/ legally authorized representative (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, Other Criteriaas judged by the Investigator

Primary outcomes:
measure: Change From Baseline in Children's Depression Rating Scale- Revised (CDRS-R)
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: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Beverly Hills
country: United States
facility: Care Access Research, Beverly Hills
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
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: Lauderdale Lakes
country: United States
facility: Zynak Clinical
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Smyrna
country: United States
facility: Attalla Consultants, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Institute
state: Georgia
city: Tyrone
country: United States
facility: Inova Clinical trials and Research Center
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR Conventions Limited
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research, Inc.
state: Illinois
city: Wichita
country: United States
facility: KU Wichita Clinical Trial Unit
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials, LLC
state: Louisiana
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Creve Coeur
country: United States
facility: Millennium Center for Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Rochester
country: United States
facility: Finger Lake Clinical Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Department of Psychiatry
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: West Chester
country: United States
facility: CincyScience
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Bellaire
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Roque Medical Trails LLC
state: Texas
city: El Campo
country: United States
facility: El Campo Clinical Trials
state: Texas
city: Frisco
country: United States
facility: Mech Healthcare Associates
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Lewisville
country: United States
facility: Northpointe Psychiatry
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. (CTT)
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Allergan
name: Daniel Radecki, PhD
role: STUDY_DIRECTOR
References: