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.

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

sites

Pacific Institute of Medical Sciences

Bothell, Washington 98011

from

Bothell, WA