Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

501

Participants

Timeline

Start Date

July 6, 2018

Primary Completion Date

March 1, 2021

Study Completion Date

March 1, 2021

Conditions
Major Depressive Disorder
Interventions
DRUG

Levomilnacipran ER

Levomilnacipran extended-release oral capsules

DRUG

Fluoxetine

Fluoxetine oral capsules

DRUG

Placebo

Matching placebo oral capsules

Trial Locations (51)

10036

Manhattan Behavioral Medicine, PLLC, New York

20910

Children's National Health System, Washington D.C.

30030

iResearch Atlanta, Decatur

30082

Attalla Consultants, LLC, Smyrna

30281

Clinical Research Institute, Stockbridge

30290

Inova Clinical trials and Research Center, Tyrone

30331

Atlanta Center for Medical Research, Atlanta

30338

Atlanta Behavioral Research, LLC, Atlanta

32256

Clinical Neuroscience Solutions, Inc, Jacksonville

32801

Clinical Neuroscience Solutions, Inc., Orlando

33030

Advanced Research Institute of Miami, Homestead

33125

Columbus Clinical Services, LLC, Miami

33313

Zynak Clinical, Lauderdale Lakes

43210

The Ohio State University Department of Psychiatry, Columbus

45040

Professional Psychiatric Services, Mason

45069

CincyScience, West Chester

45219

University of Cincinnati, Cincinnati

48307

Rochester Center for Behavioral Medicine, Rochester Hills

60048

Capstone Clinical Research, Libertyville

60563

AMR Conventions Limited, Naperville

AMR-Baber Research, Inc., Naperville

63132

Millennium Psychiatric Associates, LLC, St Louis

63141

Millennium Center for Clinical Research, Creve Coeur

67214

KU Wichita Clinical Trial Unit, Wichita

68526

Alivation Research, Lincoln

70629

Lake Charles Clinical Trials, LLC, Lake Charles

72211

Woodland International Research Group, Little Rock

73106

IPS Research, Oklahoma City

75034

Mech Healthcare Associates, Frisco

75057

Northpointe Psychiatry, Lewisville

75069

Metroplex Pulmonary and Sleep Center, McKinney

75093

AIM Trials, Plano

75243

Roque Medical Trails LLC, Dallas

77084

Biopharma Informatic, LLC, Houston

77090

Red Oak Psychiatry Associates, PA, Houston

77381

Family Psychiatry of The Woodlands, The Woodlands

77401

Houston Clinical Trials, LLC, Bellaire

77437

El Campo Clinical Trials, El Campo

78229

Clinical Trials of Texas, Inc. (CTT), San Antonio

78759

BioBehavioral Research of Austin, Austin

83642

Advanced Clinical Research, Meridian

90212

Care Access Research, Beverly Hills, Beverly Hills

90807

Alliance Research, Long Beach

91206

Behavioral Research Specialists, LLC, Glendale

92056

Excell Research, Inc., Oceanside

92251

Sun Valley Research Center, Imperial

92595

Elite Clinical Trials, Inc., Wildomar

92868

NRC Research Institute, Orange

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

98007

Northwest Clinical Research Center, Bellevue

14618-1609

Finger Lake Clinical Research, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY