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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00694707

Run by

Forest Laboratories

People needed

732

Starts

2008-06-30

Expected to finish

2009-08-31

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
• First episode of psychosis.

Where it is running

• Forest Investigative Site — Long Beach, California, United States
• Forest Investigative Site — Oceanside, California, United States
• Forest Investigative Site — Paramount, California, United States
• Forest Investigative Site — Riverside, California, United States
• Forest Investigative Site — Washington D.C., District of Columbia, United States
• Forest Investigative Site — Bradenton, Florida, United States
• Forest Investigative Site — Kissimmee, Florida, United States
• Forest Investigative Site — Lake Charles, Louisiana, United States
• Forest Investigative Site — Baltimore, Maryland, United States
• Forest Investigative Site — Flowood, Mississippi, United States
• Forest Investigative Site — Bridgeton, Missouri, United States
• Forest Investigative Site — Cincinnati, Ohio, United States
• Forest Investigative Site — Charleston, South Carolina, United States
• Forest Investigative Site — Memphis, Tennessee, United States
• Forest Investigative Site — Houston, Texas, United States
• Forest Investigative Site — Houston, Texas, United States
• Forest Investigative Site — Irving, Texas, United States
• Forest Investigative Site — Vijaywada, ANDH PRAD, India
• Forest Investigative Site — Visakhapatnam, Andh Prad, India
• Forest Investigative Site — Ahmedabad, Gujarat, India
• Forest Investigative Site — Ahmedabad, Gujarat, India
• Forest Investigative Site — Bangalore, Karna, India
• Forest Investigative Site — Bangalore, Karna, India
• Forest Investigative Site — Mangalore, Karna, India
• Forest Investigative Site — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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