Status:
COMPLETED
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
- First episode of psychosis.
Key Trial Info
Start Date :
June 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2009
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT00694707
Start Date
June 30 2008
End Date
August 31 2009
Last Update
June 12 2019
Active Locations (65)
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1
Forest Investigative Site
Costa Mesa, California, United States, 92626
2
Forest Investigative Site
Long Beach, California, United States, 90813
3
Forest Investigative Site
Oceanside, California, United States, 92056
4
Forest Investigative Site
Paramount, California, United States, 90723