Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,022

Participants

Timeline

Start Date

November 15, 2012

Primary Completion Date

June 24, 2016

Study Completion Date

June 24, 2016

Conditions
Major Depressive Disorder
Interventions
DRUG

Cariprazine

Cariprazine capsules 1.5 to 4.5 mg/day

DRUG

Placebo

Dose-matched placebo capsule once per day

DRUG

Antidepressant Therapy (ADT)

ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.

Trial Locations (85)

10023

Forest Investigative Site 016, New York

10028

Forest Investigative Site 083, New York

10305

Forest Investigative Site 025, Staten Island

10467

Forest Investigative Site 076, The Bronx

11214

Forest Investigative Site 028, Brooklyn

18104

Forest Investigative Site 052, Allentown

20850

Forest Investigative Site 077, Rockville

20852

Forest Investigative Site 012, Rockville

20877

Forest Investigative Site 049, Gaithersburg

22903

Forest Investigative Site 041, Charlottesville

27710

Forest Investigative Site 050, Durham

29425

Forest Investigative Site 001, Charleston

30060

Forest Investigative Site 017, Marietta

30306

Forest Investigative Site 060, Atlanta

30331

Forest Investigative Site 024, Atlanta

32789

Forest Investigative Site 019, Winter Park

32803

Forest Investigative Site 051, Orlando

33009

Forest Investigative Site 023, Hallandale

33012

Forest Investigative Site 071, Hialeah

33067

Forest Investigative Site 037, Coral Springs

33143

Forest Investigative Site 044, South Miami

33145

Forest Investigative Site 026, Miami

33161

Forest Investigative Site 027, North Miami

Forest Investigative Site 074, North Miami

33165

Forest Investigative Site 075, Miami

33334

Forest Investigative Site 036, Oakland Park

33613

Forest Investigative Site 008, Tampa

33912

Forest Investigative Site 053, Fort Myers

34748

Forest Investigative Site 006, Leesburg

43210

Forest Investigative Site 055, Columbus

44130

Forest Investigative Site 064, Middleburg Heights

44718

Forest Investigative Site 088, Canton

45040

Forest Investigative Site 066, Mason

45215

Forest Investigative Site 089, Cincinnati

45219

Forest Investigative Site 011, Cincinnati

45227

Forest Investigative Site 015, Cincinnati

46260

Forest Investigative Site 061, Indianapolis

47905

Forest Investigative Site 042, Lafayette

53188

Forest Investigative Site 057, Waukesha

53227

Forest Investigative Site 056, Milwaukee

58501

Forest Investigative Site 067, Bismarck

60048

Forest Investigative Site 063, Libertyville

60076

Forest Investigative Site 068, Skokie

60153

Forest Investigative Site 062, Maywood

60169

Forest Investigative Site 013, Hoffman Estates

60523

Forest Investigative Site 010, Oak Brook

60563

Forest Investigative Site 072, Naperville

60612

Forest Investigative Site 070, Chicago

63304

Forest Investigative Site 086, Saint Charles

66211

Forest Investigative Site 065, Overland Park

70115

Forest Investigative Site 073, New Orleans

72211

Forest Investigative Site 018, Little Rock

Forest Investigative Site 029, Little Rock

73103

Forest Investigative Site 035, Oklahoma City

73112

Forest Investigative Site 038, Oklahoma City

Forest Investigative Site 039, Oklahoma City

76309

Forest Investigative Site 069, Wichita Falls

77008

Forest Investigative Site 005, Houston

77381

Forest Investigative Site 087, The Woodlands

78732

Forest Investigative Site 079, Austin

80239

Forest Investigative Site 048, Denver

84058

Forest Investigative Site 030, Orem

85710

Forest Investigative Site 032, Tucson

87109

Forest Investigative Site 058, Albuquerque

90230

Forest Investigative Site 085, Culver City

90703

Forest Investigative Site 084, Cerritos

92056

Forest Investigative Site 004, Oceanside

92103

Forest Investigative Site 007, San Diego

92108

Forest Investigative Site 054, San Diego

92270

Forest Investigative Site 090, Rancho Mirage

92374

Forest Investigative Site 078, Redlands

Forest Investigative Site 080, Redlands

92591

Forest Investigative Site 031, Temecula

92660

Forest Investigative Site 022, Newport Beach

92845

Forest Investigative Site 082, Garden Grove

97210

Forest Investigative Site 003, Portland

98007

Forest Investigative Site 081, Bellevue

98104

Forest Investigative Site 043, Seattle

30080-6315

Forest Investigative Site 047, Smyrna

02131

Forest Investigative Site 046, Boston

01760

Forest Investigative Site 045, Natick

08755

Forest Investigative Site 014, Toms River

02865

Forest Investigative Site 059, Lincoln

00918

Forest Investigative Site 033, San Juan

00927

Forest Investigative Site 034, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gedeon Richter Ltd.

INDUSTRY

lead

Forest Laboratories

INDUSTRY

NCT01715805 - Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) | Biotech Hunter | Biotech Hunter