Safety and Efficacy of Cariprazine in Schizophrenia

• Status: Completed
• Trial end date: 2011-12-15
• 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: 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)

• 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