Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Last updated: October 26, 2018
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT01104766
RGH-MD-04
  • Ages 18-60
  • All Genders

Study Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have provided informed consent prior to any study specific procedures

  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,disorganized type, catatonic type or undifferentiated type), as confirmed by theStructured Clinical Interview for Diagnostic and Statistical Manual of MentalDisorders, Fourth Edition (SCID)

  • Patients with normal physical examination, laboratory, vital signs,and/ orelectrocardiogram (ECG)

  • Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1

  • Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)total score ≥ 80 and ≤ 120

  • CGI-S score ≥ 4

Exclusion

Exclusion Criteria:

  • Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders

  • Bipolar I and II disorder

  • Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic andother cognitive disorders

  • DSM-IV-TR axis II disorder of sufficient severity to interfere with participation inthis study

  • Women who are pregnant or breast feeding

Study Design

Total Participants: 617
Study Start date:
April 23, 2010
Estimated Completion Date:
December 20, 2011

Connect with a study center

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

    Bucuresti, 041914
    Romania

    Site Not Available

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

    Bucuresti, 41914
    Romania

    Site Not Available

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

    Bucuresti, 41914
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III

    Cluj-Napoca, 400012
    Romania

    Site Not Available

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

    Craiova, 200745
    Romania

    Site Not Available

  • Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie

    Craiova, 200620
    Romania

    Site Not Available

  • Spitalul Judetean de Urgenta Piatra Neamt

    Piatra Neamt, 610136
    Romania

    Site Not Available

  • Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie

    Pitesti, 110069
    Romania

    Site Not Available

  • Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu

    Sibiu, 550082
    Romania

    Site Not Available

  • Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie

    Targoviste, 130086
    Romania

    Site Not Available

  • Spitalul Clinic Judetean Mures, Clinica Psihiatrie I

    Targu Mures, 540142
    Romania

    Site Not Available

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

    Timisoara, 300736
    Romania

    Site Not Available

  • Healthcare Institution "Moscow Regional Mental Hospital #5"

    Orekhovo-Zuyevo, Moscow Region 142601
    Russian Federation

    Site Not Available

  • State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>

    Arkhangelsk, 163530
    Russian Federation

    Site Not Available

  • State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

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

    Chita, 672090
    Russian Federation

    Site Not Available

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

    Gatchina, 188357
    Russian Federation

    Site Not Available

  • Forest Investigative Site 114

    Moscow, 117152
    Russian Federation

    Site Not Available

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

    Saratov, 410028
    Russian Federation

    Site Not Available

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

    Saratov, 410060
    Russian Federation

    Site Not Available

  • 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

    St. Petersburg, 192019
    Russian Federation

    Site Not Available

  • 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

    St. Petersburg, 1922019
    Russian Federation

    Site Not Available

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

    St. Petersburg, 197341
    Russian Federation

    Site Not Available

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

    St. Petersburg, 193167
    Russian Federation

    Site Not Available

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

    St. Petersburg, 190121
    Russian Federation

    Site Not Available

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

    St. Petersburg, 192019
    Russian Federation

    Site Not Available

  • Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"

    Tomsk, 634014
    Russian Federation

    Site Not Available

  • Forest Investigative Site 211

    Glevakha, Kyiv 08613
    Ukraine

    Site Not Available

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

    Village Glevakha, Kyiv 08613
    Ukraine

    Site Not Available

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

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

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

    Dnipropetrovsk, 49027
    Ukraine

    Site Not Available

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

    Donetsk, 83008
    Ukraine

    Site Not Available

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

    Kharkiv, 61068
    Ukraine

    Site Not Available

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

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Forest Investigative Site 204

    Kharkov, 61068
    Ukraine

    Site Not Available

  • Kherson Regional Psychiatric Hospital, Department #3

    Kherson, 73488
    Ukraine

    Site Not Available

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

    Kyiv, 04080
    Ukraine

    Site Not Available

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

    Lviv, 79021
    Ukraine

    Site Not Available

  • 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, 36006
    Ukraine

    Site Not Available

  • 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, 95006
    Ukraine

    Site Not Available

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

    Vinnytsya, 49005
    Ukraine

    Site Not Available

  • Woodland International Research Group, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Woodland Research Northwest, LLC

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Synergy Clinical Research of Escondido

    Escondido, California 92025
    United States

    Site Not Available

  • Excell Research, Inc

    Oceanside, California 92056
    United States

    Site Not Available

  • Clinical Innovations, Inc.

    Riverside, California 92506
    United States

    Site Not Available

  • Sharp Mesa Vista Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Collaborative Neuroscience Network, Inc.

    Torrance, California 90502
    United States

    Site Not Available

  • Colorado Clinical Trials, Inc.

    Littleton, Colorado 80130
    United States

    Site Not Available

  • Comprehensive Clinical Development, Inc.

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Hawaii Clinical Research Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Uptown Research Institute, LLC

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Precise Research Centers

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Millennium Psychiatric Associates, LLC

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • CRI Worldwide, LLC

    Willingboro, New Jersey 08046
    United States

    Site Not Available

  • Windsor-Laurelwood Center for Behavioral Medicine

    Willoughby, Ohio 44094
    United States

    Site Not Available

  • Vanderbilt Psychiatric Hospital

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Claghorn-Lesem Research Clinic, Ltd.

    Houston, Texas 77008
    United States

    Site Not Available

  • Pacific Institute of Medical Sciences

    Bothell, Washington 98011
    United States

    Site Not Available

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