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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Antipsychotic Agents; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)