Safety and Efficacy of Cariprazine in Patients With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

617

Participants

Timeline

Start Date

April 23, 2010

Primary Completion Date

December 20, 2011

Study Completion Date

December 20, 2011

Conditions
Schizophrenia
Interventions
DRUG

Cariprazine

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

DRUG

Aripiprazole

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

Trial Locations (58)

20016

Comprehensive Clinical Development, Inc., Washington D.C.

34208

Florida Clinical Research Center, LLC, Bradenton

36006

O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology, Poltava

37212

Vanderbilt Psychiatric Hospital, Nashville

39232

Precise Research Centers, Flowood

41914

Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie, Bucharest

Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie, Bucharest

44094

Windsor-Laurelwood Center for Behavioral Medicine, Willoughby

49005

I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology, Dnipropetrovsk

O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology, Vinnytsia

49027

Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology, Dnipropetrovsk

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

60640

Uptown Research Institute, LLC, Chicago

61068

Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14, Kharkiv

State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology, Kharkiv

63141

Millennium Psychiatric Associates, LLC, Creve Coeur

72211

Woodland International Research Group, Inc., Little Rock

72764

Woodland Research Northwest, LLC, Springdale

73488

Kherson Regional Psychiatric Hospital, Department #3, Kherson

77008

Claghorn-Lesem Research Clinic, Ltd., Houston

79021

Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female), Lviv

80130

Colorado Clinical Trials, Inc., Littleton

83008

Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology, Donetsk

90502

Collaborative Neuroscience Network, Inc., Torrance

92025

Synergy Clinical Research of Escondido, Escondido

92056

Excell Research, Inc, Oceanside

92123

Sharp Mesa Vista Hospital, San Diego

92506

Clinical Innovations, Inc., Riverside

95006

Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology, Simferopol

96813

Hawaii Clinical Research Center, Honolulu

98011

Pacific Institute of Medical Sciences, Bothell

110069

Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie, Piteşti

130086

Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie, Târgovişte

142601

"Healthcare Institution Moscow Regional Mental Hospital #5", Orekhovo-Zuyevo

163530

State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>, Arkhangelsk

188357

"St. Petersburg State Healthcare Institution Mental Hospital #1 named after P.P Kashchenko", Gatchina

190121

"St. Petersburg State Healthcare Institution St. Nicholas the Wonderworker Mental Hospital", Saint Petersburg

192019

"Federal State Budget Institution St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients", Saint Petersburg

"State institution St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev", Saint Petersburg

193167

"St. Petersburg State Healthcare Institution City Mental Hospital #6 (hospital and Dispensary)", Saint Petersburg

197341

"St. Petersburg State Healthcare Institution City Mental Hospital #3 named after I.I Skvortsov-Stepanov, department #7", Saint Petersburg

200620

Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie, Craiova

200745

Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie, Craiova

300736

"Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie eduard Pamfil", Timișoara

400012

Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III, Cluj-Napoca

410028

"Municipal Healthcare Institution City Clinical Hospital #2 named after V.I Razumovsky", Saratov

410060

"State Healthcare Institution Saratov Saint Sophia Regional Mental Hospital", Saratov

454087

"State Healthcare Institution Regional Clinical Specialized Psychoneurological Hospital #1", Chelyabinsk

540142

Spitalul Clinic Judetean Mures, Clinica Psihiatrie I, Târgu Mureş

550082

"Spitalul de Psihiatrie Dr. Gheorghe Preda Sibiu", Sibiu

610136

Spitalul Judetean de Urgenta Piatra Neamt, Piatra Neamţ

634014

"Regional State Healthcare Institution Tomsk Clinical Mental Hospital", Tomsk

672090

"State Educational Institution of High Professional Education Chita State Medical Academy of Roszdrav", Chita

1922019

"Federal State Budget Institution St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev of the Minitstry of Health and Social Development of the Russian Federation", Saint Petersburg

08046

CRI Worldwide, LLC, Willingboro

041914

"Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Clinica X Psihiatrie", Bucharest

08613

Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14, Village Glevakha

04080

Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gedeon Richter Ltd.

INDUSTRY

lead

Forest Laboratories

INDUSTRY