Safety and Efficacy of Cariprazine in Patients With Schizophrenia

October 26, 2018 updated by: Forest Laboratories

A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
      • Bucuresti, Romania, 41914
        • Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
      • Bucuresti, Romania, 41914
        • Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
      • Cluj-Napoca, Romania, 400012
        • Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
      • Craiova, Romania, 200620
        • Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
      • Craiova, Romania, 200745
        • Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
      • Piatra Neamt, Romania, 610136
        • Spitalul Judetean de Urgenta Piatra Neamt
      • Pitesti, Romania, 110069
        • Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
      • Sibiu, Romania, 550082
        • Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
      • Targoviste, Romania, 130086
        • Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
      • Targu Mures, Romania, 540142
        • Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
      • Timisoara, Romania, 300736
        • Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163530
        • State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
      • Chelyabinsk, Russian Federation, 454087
        • State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
      • Chita, Russian Federation, 672090
        • State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
      • Gatchina, Russian Federation, 188357
        • St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
      • Saratov, Russian Federation, 410028
        • Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
      • Saratov, Russian Federation, 410060
        • State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
      • St. Petersburg, Russian Federation, 190121
        • St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
      • St. Petersburg, Russian Federation, 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
      • St. Petersburg, Russian Federation, 192019
        • State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
      • St. Petersburg, Russian Federation, 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
      • St. Petersburg, Russian Federation, 193167
        • St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
      • St. Petersburg, Russian Federation, 197341
        • St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
      • Tomsk, Russian Federation, 634014
        • Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
    • Moscow Region
      • Orekhovo-Zuyevo, Moscow Region, Russian Federation, 142601
        • Healthcare Institution "Moscow Regional Mental Hospital #5"
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
      • Dnipropetrovsk, Ukraine, 49027
        • Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
      • Donetsk, Ukraine, 83008
        • Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
      • Kharkiv, Ukraine, 61068
        • Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
      • Kharkiv, Ukraine, 61068
        • State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
      • Kherson, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital, Department #3
      • Kyiv, Ukraine, 04080
        • Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
      • Lviv, Ukraine, 79021
        • Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
      • Poltava, Ukraine, 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
      • Simferopol, Ukraine, 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
      • Vinnytsya, Ukraine, 49005
        • O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
    • Kyiv
      • Village Glevakha, Kyiv, Ukraine, 08613
        • Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group, Inc.
      • Springdale, Arkansas, United States, 72764
        • Woodland Research Northwest, LLC
    • California
      • Escondido, California, United States, 92025
        • Synergy Clinical Research of Escondido
      • Oceanside, California, United States, 92056
        • Excell Research, Inc
      • Riverside, California, United States, 92506
        • Clinical Innovations, Inc.
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network, Inc.
    • Colorado
      • Littleton, Colorado, United States, 80130
        • Colorado Clinical Trials, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Comprehensive Clinical Development, Inc.
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Clinical Research Center
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute, LLC
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Millennium Psychiatric Associates, LLC
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide, LLC
    • Ohio
      • Willoughby, Ohio, United States, 44094
        • Windsor-Laurelwood Center for Behavioral Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Psychiatric Hospital
    • Texas
      • Houston, Texas, United States, 77008
        • Claghorn-Lesem Research Clinic, Ltd.
    • Washington
      • Bothell, Washington, United States, 98011
        • Pacific Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (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 Criteria:

  • Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
  • Bipolar I and II disorder
  • Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
  • DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
  • Women who are pregnant or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cariprazine 3mg
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: 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.
Other Names:
  • RGH-188
EXPERIMENTAL: Cariprazine 6mg
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: 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.
Other Names:
  • RGH-188
ACTIVE_COMPARATOR: Aripiprazole 10mg
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: 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.
PLACEBO_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.
Time Frame: Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Time Frame: Baseline to Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 23, 2010

Primary Completion (ACTUAL)

December 20, 2011

Study Completion (ACTUAL)

December 20, 2011

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (ESTIMATE)

April 15, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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