A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

PHASE3CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

September 30, 2016

Study Completion Date

October 31, 2016

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 (44)

10168

Alkermes Investigational Site, New York

10245

Alkermes Investigational Site, Berlin

10629

Alkermes Investigational Site, Berlin

16515

Alkermes Investigational Site, Oranienburg

18439

Alkermes Investigational Site, Stralsund

19053

Alkermes Investigational Site, Schwerin

27265

Alkermes Investigational Site, High Point

30080

Alkermes Investigational Site, Smyrna

30159

Alkermes Investigational Site, Hanover

32901

Alkermes Investigational Site, Melbourne

33161

Alkermes Investigational Site, North Miami

33334

Alkermes Investigational Site, Oakland Park

33880

Alkermes Investigational Site, Winter Haven

33912

Alkermes Investigational Site, Fort Myers

34201

Alkermes Investigational Site, Bradenton

35294

Alkermes Investigational Site, Birmingham

38119

Alkermes Investigational Site, Memphis

39232

Alkermes Investigational Site, Flowood

44718

Alkermes Investigational Site, Canton

60169

Alkermes Investigational Site, Hoffman Estates

63141

Alkermes Investigational Site, St Louis

63304

Alkermes Investigational Site, Saint Charles

75115

Alkermes Investigational Site, DeSoto

76309

Alkermes Investigational Site, Wichita Falls

80910

Alkermes Investigational Site, Colorado Springs

84015

Alkermes Investigational Site, Clinton

90024

Alkermes Investigational Site, Los Angeles

90660

Alkermes Investigational Site, Pico Rivera

91776

Alkermes Investigational Site, San Gabriel

92056

Alkermes Investigational Site, Oceanside

92324

Alkermes Investigational Site, Colton

92845

Alkermes Investigational Site, Garden Grove

94612

Alkermes Investigational Site, Oakland

97214

Alkermes Investigational Site, Portland

98007

Alkermes Investigational Site, Bellevue

98104

Alkermes Investigational Site, Seattle

99204

Alkermes Investigational Site, Spokane

08540

Alkermes Investigational Site, Princeton

J8T 8J1

Alkermes Investigational Site, Gatineau

B3S 1M7

Alkermes Investigational Site, Halifax

V2A 4M4

Alkermes Investigational Site, Penticton

G3K 2P8

Alkermes Investigational Site, Québec

00918

Alkermes Investigational Site, San Juan

00926

Alkermes Investigational Site, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY