Safety and Efficacy of Cariprazine in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2011-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Aripiprazole; Cariprazine

Criteria

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