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

PHASE3CompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

June 23, 2015

Primary Completion Date

August 19, 2019

Study Completion Date

August 19, 2019

Conditions
Major Depressive Disorder
Interventions
DRUG

Placebo

Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.

DRUG

Levomilnacipran

Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.

DRUG

Fluoxetine

Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.

Trial Locations (49)

10036

Manhattan Behavioral Medicine, New York

22903

UVA Child and Family Psychiatry Clinic, Charlottesville

24014

Carilion Medical Center, Roanoke

30281

Clinical Research Institute, Stockbridge

30331

Atlanta Center for Medical Research, Atlanta

32034

Coastal Clinical Research Specialists, Fernandina Beach

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32405

NeuroMedical Institute, Panama

32763

Medical Research Group of Central Florida, Orange City

32801

Clinical Neuroscience Solutions, Inc., Orlando

33013

Research in Miami Inc, Hialeah

33030

Advanced Research Institute of Miami, Homestead

33319

Innovative Clinical Research, Inc., Lauderhill

33613

University of South Florida Board of Trustee, Tampa

33912

Gulfcoast Clinical Research Center, Fort Myers

34201

Florida Clinical Research Center; LLC, Bradenton

36303

Harmonex, Inc, Dothan

40004

Kentucky Pediatric Research, Bardstown

45040

Professional Psychiatric Services, Mason

45417

Midwest Clinical Research Center, Dayton

60563

Sandeep Gaonkar, MD, Naperville

68526

Alivation Research, Lincoln

73106

IPS Research Company, Oklahoma City

73112

Sooner Clinical Research, Oklahoma City

73116

Cutting Edge Research Group, Oklahoma City

73118

Paradigm Research Professionals, Oklahoma City

74104

Tulsa Clinical Research, LLC, Tulsa

77054

UTHSC-Houston, Houston

77058

Bay Area Clinical Services dba Earle Research, Houston

77090

Red Oak Psychiatry Associates, Houston

77381

Family Psychiatry of The Woodlands, The Woodlands

80910

MCB Clinical Research Center, Colorado Springs

85724

University of Arizona Department of Psychiatry, Tucson

89102

Kolade Research Institute, Las Vegas

90230

ProScience Research Group, Culver City

90807

Alliance for Research, Long Beach

91402

Asclepes Research Centers, Panorama City

91786

Pacific Clinical Research Medical Group, Upland

92251

Sun Valley Research Center, Imperial

92801

Advanced Research Center, Inc., Anaheim

97025

Syrentis Clinical Research, Santa Ana

97301

Oregon Center for Clinical Investigations, Inc., Salem

98007

Northwest Clinical Research Center, Bellevue

98201

Eastside Therapeutic Resource dba Core Clinical, Everett

30080-2620

Institute for Behavioral Medicine, Smyrna

02472

Adams Clinical Trials, LLC, Watertown

03060

Healthy Perspectives - Innovative Mental Health Services. PLLC, Nashua

08540

Princeton Medical Institute, Princeton

00918

INSPIRA Clinical Research, San Juan

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY