Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder, Psychotic Disorders

In brief

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.

Key facts

Study ID

NCT00535145

Run by

Ortho-McNeil Janssen Scientific Affairs, LLC

People needed

121

Starts

2007-10-01

Expected to finish

2009-02-01

Last updated by the study team

2014-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
• Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
• Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
• Child-Pugh class A or B (total score < 10)

You may not qualify if…

• Not able to swallow the study medication whole with the aid of water
• Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV diagnosis of Bipolar Disorder
• Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance abuse or dependence or alcohol abuse or dependence in the 6 months before study entry
• Not experiencing severe liver disease or an acute exacerbation of the underlying liver disease (Child-Pugh total score >=10)
• No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)

Where it is running

• Study site — Cerritos, California, United States
• Study site — Chino, California, United States
• Study site — Garden Grove, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Santa Ana, California, United States
• Study site — Torrance, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Flowood, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Clementon, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Staten Island, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Irving, Texas, United States
• Study site — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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