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

Major Depressive Disorder (MDD) 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: Recruiting

Administrative data

• NCT number: NCT03087916
• Other study ID #: LVM-MD-11
• Status: Recruiting
• Phase: Phase 3
• First received: March 16, 2017
• Last updated: March 16, 2017
• Start date: June 2015
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Allergan
• Contact: Allergan, Inc.
• Email: clinicaltrials[@]allergan.com
• 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

Patients 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Key Inclusion Criteria:

1. Male or female outpatients;12-17 years of age

2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD) , confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)

3. Score = 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2

4. Clinical Global Impressions-Severity (CGI-S) score = 4 at Visits 1 and 2

5. Reliable caregiver

6. Physical examination, vital signs, clinical laboratory tests, and ECG normal or not clinically significant

Key Psychiatric Exclusion Criteria:

1. DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment

2. Mental retardation or amnestic or other cognitive disorders

• 3) Significant suicide risk:

• Suicide attempt within the past year OR

• Investigator judgment (based on psychiatric interview and C-SSRS)

Key Treatment-Related Exclusion Criteria:

1. Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)

2. Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

1. Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect patient safety

2. Liver enzyme tests (aspartate aminotransferase) AST and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)

3. Clinically significant cardiovascular disorders

4. Seizure disorder or risk of seizure

5. Drug or alcohol abuse or dependence (within the past year)

6. Positive urine drug screen or blood alcohol

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Placebo

• Levomilnacipran ER

• Fluoxetine

Locations

Country	Name	City	State
Puerto Rico	Investigative Site 031	San Juan
Puerto Rico	Investigative Site 034	San Juan
Puerto Rico	Investigative Site 046	San Juan
United States	Investigative Site 045	Amherst	New York
United States	Investigative Site 013	Anaheim	California
United States	Investigative Site 036	Anaheim	California
United States	Investigative Site 030	Bardstown	Kentucky
United States	Investigative Site 072	Bellvue	Washington
United States	Investigative Site 027	Bloomfield	Michigan
United States	Investigative Site 019	Bradenton	Florida
United States	Investigative Site 005	Charleston	South Carolina
United States	Investigative Site 037	Charlottesville	Virginia
United States	Investigative Site 026	Cincinnati	Ohio
United States	Investigative Site 028	Cleveland	Ohio
United States	Investigative Site 057	Cleveland	Ohio
United States	Investigative Site 033	Colton	California
United States	Investigative Site 024	Culver City	California
United States	Investigative Site 050	Dayton	Ohio
United States	Investigative Site 021	Fort Myers	Florida
United States	Investigative Site 015	Garfield Heights	Ohio
United States	Investigative Site 022	Gresham	Oregon
United States	Investigative Site 051	Homestead	Florida
United States	Investigative Site 009	Houston	Texas
United States	Investigative Site 029	Houston	Texas
United States	Investigative Site 062	Houston	Texas
United States	Investigative Site 003	Imperial	California
United States	Investigative Site 010	Irvine	California
United States	Investigative Site 011	Jacksonville	Florida
United States	Investigative Site 069	Jacksonville Beach	Florida
United States	Investigative Site 067	La Palma	California
United States	Investigative Site 054	Las Vegas	Nevada
United States	Investigative Site 068	Libertyville	Illinois
United States	Investigative Site 002	Lincoln	Nebraska
United States	Investigative Site 001	Little Rock	Arkansas
United States	Investigative Site 071	Long Beach	California
United States	Investigative Site 078	Long Beach	California
United States	Investigative Site 006	Louisville	Kentucky
United States	Investigative Site 060	Marlton	New Jersey
United States	Investigative Site 044	Mason	Ohio
United States	Investigative Site 048	Melbourne	Florida
United States	Investigative Site 039	Naperville	Illinois
United States	Investigative Site 055	Nashville	Tennessee
United States	Investigative Site 008	New York	New York
United States	Investigative Site 063	New York	New York
United States	Investigative Site 070	Norwich	Connecticut
United States	Investigative Site 052	Oklahoma	Oklahoma
United States	Investigative Site 053	Oklahoma	Oklahoma
United States	Investigative Site 058	Oklahoma City	Oklahoma
United States	Investigative Site 042	Orlando	Florida
United States	Investigative Site 066	Orlando	Florida
United States	Investigative Site 041	Panama City	Florida
United States	Investigative Site 077	Panorama City	California
United States	Investigative Site 043	Petersburg	Virginia
United States	Investigative Site 075	Phoenix	Arizona
United States	Investigative Site 023	Portland	Oregon
United States	Investigative Site 025	Princeton	New Jersey
United States	Investigative Site 061	Richmond	Virginia
United States	Investigative Site 012	Riverside	California
United States	Investigative Site 076	Roanoke	Virginia
United States	Investigative Site 038	Saint Petersburg	Florida
United States	Investigative Site 073	Salem	Oregon
United States	Investigative Site 014	San Francisco	California
United States	Investigative Site 018	Sanford	Florida
United States	Investigative Site 049	Searcy	Arkansas
United States	Investigative Site 020	Seattle	Washington
United States	Investigative Site 007	Smyrna	Georgia
United States	Investigative Site 059	Springdale	Arkansas
United States	Investigative Site 056	Stockbridge	Georgia
United States	Investigative Site 017	Tampa	Florida
United States	Investigative Site 032	Tampa	Florida
United States	Investigative Site 047	Tampa	Florida
United States	Investigative Site 004	Tucson	Arizona
United States	Investigative Site 035	Tulsa	Oklahoma
United States	Investigative Site 065	Upland	California
United States	Investigative Site 040	Vernon Hills	Illinois
United States	Investigative Site 074	Watertown	Massachusetts
United States	Investigative Site 016	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Children's Depression Rating Scale-Revised (CDRS-R) total score	The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years and contains 17 items that evaluate the presence and severity of symptoms commonly associated with childhood depression. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression.	From Baseline to end of Week 8
Secondary	Change in Clinical Global Impression-Severity (CGI-S) scale	The CGI-S is a clinician-rated scale used to rate the severity of the patient's current state of mental illness compared with an MDD patient population. The patient will be rated on a scale from 1 to 7, with 1 indicating "normal, not at all ill" and 7 indicating "among the most extremely ill patients."	From Baseline to end of Week 8

External Links

•   Please visit http://actavissitesupport.com/SelectStudy.aspx