A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Key facts

Study ID

NCT00839852

Run by

Forest Laboratories

People needed

97

Starts

2009-05-31

Expected to finish

2010-08-31

Last updated by the study team

2019-08-22

Who can join

Age: 18 and older, up to 61. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
• Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
• Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
• Patients must have a caregiver to ensure treatment compliance.

You may not qualify if…

• Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

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 — Creve Coeur, 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 — 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 — Mangalore, Karna, India
• Forest Investigative Site — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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