Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

• Status: Completed
• Trial end date: 2009-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or female, 18 to 60 years of age.

• Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).

• Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.

• Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.

• First episode of psychosis.