Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

PHASE2CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

December 6, 2010

Study Completion Date

December 6, 2010

Conditions
Major Depressive Disorder
Interventions
DRUG

Antidepressant + placebo

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

DRUG

Antidepressant + cariprazine (0.1-0.3 mg/day)

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

DRUG

Antidepressant + cariprazine (1-2 mg/d)

Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Trial Locations (41)

10003

Forest Investigative Site 039, New York

10021

Forest Investigative Site 029, New York

10467

Forest Investigative Site 001, The Bronx

10549

Forest Investigative Site 020, Mount Kisco

11235

Forest Investigative Site 043, Brooklyn

19063

Forest Investigative Site 006, Media

19104

Forest Investigative Site, Philadelphia

19107

Forest Investigative Site, Philadelphia

20016

Forest Investigative Site, Washington D.C.

23230

Forest Investigative Site, Richmond

27607

Forest Investigative Site 032, Raleigh

30076

Forest Investigative Site, Roswell

30306

Forest Investigative Site 033, Atlanta

32216

Forest Investigative Site 007, Jacksonville

33407

Forest Investigative Site 012, West Palm Beach

37212

Forest Investigative Site, Nashville

38119

Forest Investigative Site 023, Memphis

Forest Investigative Site 031, Memphis

44718

Forest Investigative Site, Canton

45417

Forest Investigative Site, Dayton

66211

Forest Investigative Site, Overland Park

68131

Forest Investigative Site, Omaha

78229

Forest Investigative Site, San Antonio

80239

Forest Investigative Site 025, Denver

85050

Forest Investigative Site 040, Phoenix

85254

Forest Investigative Site 038, Scottsdale

90720

Forest Investigative Site 013, Los Alamitos

91007

Forest Investigative Site, Arcadia

91316

Forest Investigative Site, Encino

91950

Forest Investigative Site 041, National City

92056

Forest Investigative Site, Oceanside

92618

Forest Investigative Site, Irvine

92845

Forest Investigative Site, Garden Grove

97210

Forest Investigative Site 015, Portland

98007

Forest Investigative Site, Bellevue

98104

Forest Investigative Site, Seattle

06360

Forest Investigative Site, Norwich

02721

Forest Investigative Site 042, Fall River

01267

Forest Investigative Site 034, Pittsfield

08002

Forest Investigative Site, Cherry Hill

05091

Forest Investigative Site, Woodstock

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gedeon Richter Ltd.

INDUSTRY

lead

Forest Laboratories

INDUSTRY