Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 10/31/2018 |
Start Date: | April 23, 2010 |
End Date: | December 20, 2011 |
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.
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)
- 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
We found this trial at
21
sites
8043 Cooper Creek Boulevard
Suite 107
Bradenton, Florida 34201
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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