Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

493

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

January 18, 2018

Study Completion Date

January 18, 2018

Conditions
Bipolar DisorderDepression
Interventions
DRUG

Cariprazine

Cariprazine capsule one per day orally.

DRUG

Placebo

Matching placebo capsule one per day orally.

Trial Locations (89)

4000

"UMHAT Sv. Georgi, EAD", Plovdiv

5800

UMHAT 'Dr. Georgi Stranski', Dept. of Psychiatry, Pleven

6100

"MHAT Dr. Hristo Stambolski, EOOD", Kazanlak

8001

Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD, Burgas

9020

"DCC Mladost M - Varna, OOD Site 188", Varna

"DCC Mladost M - Varna, OOD Site 194", Varna

10000

Polyclinic Neuron, Zagreb

University Hospital Center Zagreb, Zagreb

10036

Manhattan Behavioral Medicine, New York

10090

Clinic for Psychiatry Vrapce, Zagreb

"Psychiatric Hospital Sveti Ivan", Zagreb

10128

Eastside Comprehensive Medical Center, New York

11000

"Clinic of Psychiatric Diseases Dr Laza Lazarevic", Belgrade

Clinical Center of Serbia, Belgrade

Clinical Center Zvezdara, Belgrade

General Hospital Euromedic, Belgrade

Institute of Mental Health, Belgrade

11040

"Clinical Center Dr. Dragisa Misovic", Belgrade

11214

Brooklyn Medical Institute, Brooklyn

11235

SPRI Clinical Trials, LLC, Brooklyn

14215

University at Buffalo Erie County Medical Center, Buffalo

14618

Finger Lakes Clinical Research, Rochester

18000

Clinical Center Nis Site 150, Niš

Clinical Center Nis Site 160, Niš

19063

Suburban Research Associates, Media

20016

Comprehensive Clinical Research, Washington D.C.

20708

CI Cherkasy Regional Psychiatric Hospital of ChRC, Smila

21005

CI O.I. Yushchenko Vinnytsia Reg. Psychoneurological Hospital, Vinnytsia

23330

"Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi", Novi Kneževac

28601

Clinical Trials of America, Inc, Hickory

29407

Carolina Clinical Trials, Inc., Charleston

30331

Atlanta Center for Medical Research, Atlanta

33009

MD Clinical, Hallandale

33067

CNS Clinical Research Group, Coral Springs

33133

Innova Clinical Trials, Inc., Miami

33319

Innovative Clinical Research, Inc., Lauderhill

33334

Research Centers of America, LLC, Oakland Park

34000

Clinical Center Kragujevac Site 154, Kragujevac

Clinical Centre Kragujevac Site 158, Kragujevac

35294

University of Alabama at Birmingham, Birmingham

36303

Harmonex Neuroscience Research, Inc., Dothan

44317

Neuropsychiatric Hospital Ivan Barbot, Popovača

45040

Professional Psychiatric Services, Mason

45219

University of Cincinnati - Department of Psychiatry and Behavioral Neuroscience, Cincinnati

46027

Ternopil Reg. Communal Clinical Psychoneurological Hospital Depts of Psychiatry #2, Ternopil

51000

Clinical Hospital Center Rijeka, Rijeka

60048

Capstone Clinical Research, Libertyville

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

60563

Baber Research Group, Naperville

61068

SI Inst.of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv

63141

Millennium Psychiatric Associates, Creve Coeur

St. Louis Clinical Trials, LLC, St Louis

65006

CI Odesa Regional Medical Center of Mental Health, Odesa

67513

CI Odesa Regional Psychiatric Hospital # 2, Komintern

71104

J. Gary Booker, MD, APMC, Shreveport

72211

Woodland International Research Group, LLC, Little Rock

73116

Cutting Edge Research Group, Oklahoma City

73488

CI Kherson Reg. Psychiatric Hospital of Kherson RC, Kherson

74104

Tulsa Clinical Research, LLC, Tulsa

76014

Regional Psychoneurological Hospital #3, Dept of Primary Psych Episode, Ivano-Frankivsk

Regional Psychoneurological Hospital #3, Ivano-Frankivsk

76309

Grayline Research Center, Wichita Falls

77079

Houston Endoscopy and Research Center, Houston

79017

CI of LRC Lviv Reg. Council Lviv Reg.Clinical Psychoneurological Dispensary, Lviv

85032

NoesisPharma, LLC, Phoenix

85101

Vavrusova Consulting s.r.o., Bratislava

88000

Transcarpathian Regional Narcological Dispensary, Uzhhorod

90502

Collaborative Neuroscience Network, LLC, Torrance

90703

Radiant Research, Cerritos

91206

Behavioral Research Specialists, LLC, Glendale

92056

Excell Research, Inc., Oceanside

92805

Advanced Research Center, Inc, Anaheim

92845

Collaborative Neuroscience Network, LLC, Garden Grove

97901

PsychoLine s.r.o., Rimavská Sobota

98011

Pacific Institute of Medical Sciences, Bothell

700282

Institutul de Psihiatrie Socola Iasi Site 111, Iași

Institutul de Psihiatrie Socola Iasi Site 113, Iași

800179

"Spitalul de Psihiatrie Elisabeta Doamna Galati", Galati

02190

Coastal Research Associates, Inc., Weymouth

08002

Center for Emotional Fitness, Cherry Hill

08053

Pharmaceutical Research Associates, Inc., Marlton

00926

Barbara Diaz-Hernandez MD Research, Inc., San Juan

010825

"Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila", Bucharest

030442

"Spitalul de Psihiatrie Titan Dr. Constantin Gorgos", Bucharest

08501

Centrum zdravia R.B.K. s.r.o., Bardejov

03123

Liptovska nemocnica s poliklinikou Liptovsky Mikulas, Liptovský Mikuláš

04801

Nemocnica s poliklinikou sv. Barbory, Roznava a.s., Rožňava

09301

Crystal Comfort s.r.o., Vranov nad Topľou

08631

CI of Kyiv Reg.Council Reg.Psychiatric-Narcological Medical Association, Hlevakha

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY

NCT02670538 - Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder | Biotech Hunter | Biotech Hunter