A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

PHASE3CompletedINTERVENTIONAL
Enrollment

385

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

High Dose ALKS 5461

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

DRUG

Low Dose 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 (49)

3004

Alkermes Investigational Site, Melbourne

3199

Alkermes Investigational Site, Frankston

4000

Alkermes Investigational Site, Brisbane

4066

Alkermes Investigational Site, Towong

10128

Alkermes Investigational Site, New York

10305

Alkermes Investigational Site, Staten Island

10549

Alkermes Investigational Site, Mount Kisco

11241

Alkermes Investigational Site, Brooklyn

18104

Alkermes Investigational Site, Allentown

19063

Alkermes Investigational Site, Media

19107

Alkermes Investigational Site, Philadelphia

21208

Alkermes Investigational Site, Baltimore

21285

Alkermes Investigational Site, Baltimore

30005

Alkermes, Investigational Site, Alpharetta

30030

Alkermes Investigational Site, Decatur

32607

Alkermes Investigational Site, Gainesville

32801

Alkermes Investigational Site, Orlando

33067

Alkermes Investigational Site, Coral Springs

33319

Alkermes Investigational Site, Lauderhill

35226

Alkermes Investigational Site, Birmingham

42301

Alkermes Investigational Site, Owensboro

44718

Alkermes Investigational Site, Canton

45417

Alkermes Investigational Site, Dayton

46383

Alkermes Investigational Site, Valparaiso

47630

Alkermes Investigational Site, Newburgh

53562

Alkermes Investigational Site, Middleton

60076

Alkermes Investigational Site, Skokie

60435

Alkermes Investigational Site, Joliet

60640

Alkermes Investigational Site, Chicago

73103

Alkermes Investigational Site, Oklahoma City

73112

Alkermes Investigational Site, Oklahoma City

77081

Alkermes Investigational Site, Houston

78229

Alkermes Investigational Site, San Antonio

78731

Alkermes Investigational Site, Austin

85712

Alkermes Investigational Site, Tucson

90502

Alkermes Investigational Site, Torrance

90746

Alkermes Investigational Site, Carson

91403

Alkermes Investigational Site, Sherman Oaks

91786

Alkermes Investigational Site, Upland

91950

Alkermes Investigational Site, National City

92868

Alkermes Investigational Site, Orange

06106

Alkermes Investigational Site, Hartford

06360

Alkermes Investigational Site, Norwich

08009

Alkermes Investigational Site, Berlin

02865

Alkermes Investigational Site, Lincoln

05091

Alkermes Investigational Site, Woodstock

Unknown

Alkermes Investigational Site, Penticton

Alkermes Investigational Site, Gatineau

Alkermes Investigational Site, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY

NCT02158533 - A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study | Biotech Hunter | Biotech Hunter