NCT01838876 - Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder | Biotech Hunter

Enrollment

442

Participants

Timeline

Start Date

April 29, 2013

Primary Completion Date

July 27, 2015

Study Completion Date

July 27, 2015

Conditions

Major Depressive Disorder

Interventions

DRUG

Cariprazine

Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.

DRUG

Antidepressant Therapy (ADT)

ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug

Trial Locations (90)

10023

Forest Investigative Site 016, 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

19403

Forest Investigative Site 102, Norristown

20850

Forest Investigative Site 077, Rockville

20852

Forest Investigative Site 110, 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

30080

Forest Investigative Site 047, Smyrna

30329

Forest Investigative Site 060, Atlanta

30331

Forest Investigative Site 024, Atlanta

32751

Forest Investigative Site 112, Maitland

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

45040

Forest Investigative Site 066, Mason

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

53562

Forest Investigative Site 101, Middleton

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 103, Saint Charles

66211

Forest Investigative Site 065, Overland Park

70115

Forest Investigative Site 073, New Orleans

72112

Forest Investigative Site 038, Oklahoma City

72211

Forest Investigative Site 018, Little Rock

Forest Investigative Site 029, Little Rock

72703

Forest Investigative Site 105, Fayetteville

73103

Forest Investigative Site 035, Oklahoma City

73112

Forest Investigative Site 039, Oklahoma City

76309

Forest Investigative Site 069, Wichita Falls

77008

Forest Investigative Site 005, Houston

77381

Forest Investigative Site 108, The Woodlands

78732

Forest Investigative Site 079, Austin

80239

Forest Investigative Site 048, Denver

84123

Forest Investigative Site 111, Murray

85710

Forest Investigative Site 032, Tucson

85724

Forest Investigative Site 109, Tucson

87109

Forest Investigative Site 058, Albuquerque

90822

Forest Investigative Site 107, Long Beach

91950

Forest Investigative Site 104, National City

92056

Forest Investigative Site 004, Oceanside

92102

Forest Investigative Site 113, San Diego

92108

Forest Investigative Site 054, San Diego

92123

Forest Investigative Site 007, San Diego

92270

Forest Investigative Site 078, Rancho Mirage

92374

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

98011

Forest Investigative Site 100, Bothell

98104

Forest Investigative Site 043, Seattle

06360

Forest Investigative Site 114, Norwich

02131

Forest Investigative Site 046, Boston

01760

Forest Investigative Site 045, Natick

08009

Forest Investigative Site 106, Berlin

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