Safety and Efficacy of Cariprazine in Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:11/16/2018
Start Date:April 27, 2010
End Date:December 15, 2011

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A Double-Blind, Placebo-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.


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)

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

- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

- Patients with normal physical examination, laboratory, vital signs,and/ or
electrocardiogram (ECG)

Exclusion Criteria:

- Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform
disorder, other psychotic disorders other than schizophrenia, or bipolar I or II
disorder

- Patients in their first episode of psychosis

- Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during
the study

- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
other cognitive disorders

- Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR
axis II disorder of sufficient severity to interfere with participation in this study

- Substance abuse or dependence within the prior 3 months
We found this trial at
16
sites
Rockville, Maryland 20850
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Rockville, MD
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Atlanta, Georgia 30328
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Atlanta, GA
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Bello, Antioquia 05105
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Bello,
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Cedarhurst, New York 11516
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Cedarhurst, NY
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Cincinnati, Ohio 45219
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Cincinnati, OH
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Costa Mesa, California 92626
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Costa Mesa, CA
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Houston, Texas 77008
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Houston, TX
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Irving, Texas 75062
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Irving, TX
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Kissimmee, Florida 34741
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Kissimmee, FL
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Long Beach, California 90813
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Long Beach, CA
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Memphis, Tennessee 38119
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Memphis, TN
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Paramount, California 90723
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Paramount, CA
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Philadelphia, Pennsylvania 19139
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Philadelphia, PA
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Saint Louis, Missouri 63141
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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