Safety and Efficacy of Cariprazine for Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

497

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
ManiaBipolar I Disorder
Interventions
DRUG

Cariprazine

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

DRUG

Placebo

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Trial Locations (66)

11000

Forest Investigative Site 403, Belgrade

Forest Investigative Site 404, Belgrade

Forest Investigative Site 405, Belgrade

11516

Forest Investigative Site 008, Cedarhurst

19139

Forest Investigative Site 019, Philadelphia

20016

Forest Investigative Site 007, Washington D.C.

20850

Forest Investigative Site 006, Rockville

24400

Forest Investigative Site 401, Senta

30308

Forest Investigative Site 026, Atlanta

32821

Forest Investigative Site 003, Orlando

34000

Forest Investigative Site 402, Kragujevac

34741

Forest Investigative Site 002, Kissimmee

36006

Forest Investigative Site 314, Poltava

38119

Forest Investigative Site 015, Memphis

46143

Forest Investigative Site 021, Greenwood

49027

Forest Investigative Site 308, Dnipropetrovsk

49115

Forest Investigative Site 315, Dnipropetrovsk

60169

Forest Investigative Site 011, Hoffman Estates

61068

Forest Investigative Site 307, Kharkiv

Forest Investigative Site 310, Kharkiv

63118

Forest Investigative Site 025, St Louis

65006

Forest Investigative Site 302, Odesa

71115

Forest Investigative Site 001, Shreveport

72211

Forest Investigative Site 018, Little Rock

75062

Forest Investigative Site 004, Irving

79021

Forest Investigative Site 311, Lviv

83008

Forest Investigative Site 301, Donetsk

90703

Forest Investigative Site 012, Cerritos

91045

Forest Investigative Site 306, Luhansk

92056

Forest Investigative Site 005, Oceanside

92102

Forest Investigative Site 023, San Diego

92103

Forest Investigative Site 017, San Diego

92626

Forest Investigative Site 010, Costa Mesa

92701

Forest Investigative Site 024, Santa Ana

96813

Forest Investigative Site 013, Honolulu

98011

Forest Investigative Site 014, Bothell

115522

Forest Investigative Site 503, Moscow

Forest Investigative Site 507, Moscow

Forest Investigative Site 510, Moscow

130086

Forest Investigative Site 204, Târgovişte

190005

Forest Investigative Site 506, Saint Petersburg

190121

Forest Investigative Site 508, Saint Petersburg

200260

Forest Investigative Site 201, Craiova

200745

Forest Investigative Site 210, Craiova

214019

Forest Investigative Site 502, Smolensk

300182

Forest Investigative Site 211, Timișoara

310022

Forest Investigative Site 209, Arad

398007

Forest Investigative Site 501, Lipetsk

410028

Forest Investigative Site 504, Saratov

443016

Forest Investigative Site 509, Samara

620165

Forest Investigative Site 212, Focşani

900002

Forest Investigative Site 202, Constanța

06050

Forest Investigative Site 016, New Britain

51 000

Forest Investigative Site 607, Rijeka

10 000

Forest Investigative Site 602, Zagreb

Forest Investigative Site 605, Zagreb

10 090

Forest Investigative Site 606, Zagreb

041915

Forest Investigative Site 203, Bucharest

Forest Investigative Site 205, Bucharest

Forest Investigative Site 206, Bucharest

Forest Investigative Site 208, Bucharest

01030

Forest Investigative Site 304, Kyiv

02660

Forest Investigative Site 305, Kyiv

04080

Forest Investigative Site 303, Kyiv

Forest Investigative Site 309, Kyiv

08631

Forest Investigative Site 312, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gedeon Richter Ltd.

INDUSTRY

lead

Forest Laboratories

INDUSTRY