A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

PHASE3CompletedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Major Depressive Disorder
Interventions
DRUG

ALKS 5461

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

DRUG

Placebo

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Trial Locations (58)

1113

Alkermes Investigational Site, Sofia

1431

Alkermes Investigational Site, Sofia

1632

Alkermes Investigational Site, Sofia

3000

Alkermes Investigational Site, Vratsa

5000

Alkermes Investigational Site, Veliko Tarnovo

6100

Alkermes Investigational Site, Kazanlak

8001

Alkermes Investigational Site, Burgas

9020

Alkermes Investigational Site, Varna

10023

Alkermes Investigational Site, New York

10312

Alkermes Investigational Site, Staten Island

11432

Alkermes Investigational Site, Jamaica

19104

Alkermes Investigational Site, Philadelphia

20016

Alkermes Investigational Site, Washington D.C.

Alkermes Investigational, Washington DC

28204

Alkermes Investigational Site, Charlotte

29407

Alkermes Investigational Site, Charleston

30331

Alkermes Investigational Site, Atlanta

32256

Alkermes Investigational Site, Jacksonville

32751

Alkermes Investigational Site, Maitland

33009

Alkermes Investigational Site, Hallandale

33016

Alkermes Investigational Site, Hialeah

33613

Alkermes Investigational Site, Tampa

34748

Alkermes Investigational Site, Leesburg

38119

Alkermes Investigational Site, Memphis

41017

Alkermes Investigational Site, Edgewood

44122

Alkermes Investigational Site, Beachwood

44130

Alkermes Investigational Site, Middleburg Heights

45040

Alkermes Investigational Site, Mason

45215

Alkermes Investigational Site, Cincinnati

45227

Alkermes Investigational Site, Cincinnati

46260

Alkermes Investigational Site, Indianapolis

47905

Alkermes Investigational Site, Lafayette

53188

Alkermes Investigational Site, Waukesha

60061

Alkermes Investigational Site, Vernon Hills

60523

Alkermes Investigational Site, Oak Brook

60634

Alkermes Investigational Site, Chicago

63109

Alkermes Investigational Site, St Louis

63368

Alkermes Investigational Site, O'Fallon

64114

Alkermes Investigational Site, Kansas City

72211

Alkermes Investigational Site, Little Rock

75231

Alkermes Investigational Site, Dallas

75309

Alkermes Investigational Site, Dallas

77098

Alkermes Investigational Site, Houston

77478

Alkermes Investigational Site, Sugar Land

87109

Alkermes Investigational Site, Albuquerque

90210

Alkermes Investigational Site, Beverly Hills

90706

Alkermes Investigational Site, Bellflower

90720

Alkermes Investigational Site, Los Alamitos

91206

Alkermes Investigational Site, Glendale

92374

Alkermes Investigational Site, Redlands

92591

Alkermes Investigational Site, Temecula

92868

Alkermes Investigational Site, Orange

97210

Alkermes Investigational Site, Portland

97301

Alkermes Investigational Site, Salem

98007

Alkermes Investigational Site, Bellevue

02301

Alkermes Investigational Site, Brockton

02472

Alkermes Investigational Site, Watertown

08002

Alkermes Investigational Site, Cherry Hill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY

NCT02158546 - A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study | Biotech Hunter | Biotech Hunter