NCT00535145

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

A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information about the safety of treatment with medications for schizophrenia in this at-risk population of patients with schizophrenia or schizoaffective disorder and liver disease. This 9-week study is open-label (both patient and investigators know what study drug and dose of study drug the patient is taking) and has 2 phases. During Phase 1, which lasts 4 weeks, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual). During the first week of Phase 2, patients will receive decreasing doses of TAU and increasing doses of paliperidone ER. For the rest of Phase 2, which lasts 4 more weeks, patients will take paliperidone ER in doses between 3 mg/day and 12 mg/day, as prescribed by the study doctor. This study will evaluate adverse events and will use several scales and tests to measure the effectiveness of paliperidone ER in patients with an established diagnosis of schizophrenia or schizoaffective disorder and liver disease. Study assessments include the PANSS (Positive and Negative Symptom Scale for Schizophrenia), CGI (Clinical Global Impression scale), MSQ (Medication Satisfaction Questionnaire), sleep VAS (Visual Analog Scale), SF-36 (Short Form 36 Health Survey), and PSP (Personal and Social Performance Scale). Each assessment will be performed at least two times during the course of the study, but some assessments will be done more frequently. Visits are scheduled every 1 to two weeks during the 9 week study. The hypothesis is that paliperidone ER can be used safely in patients with schizophrenia or schizoaffective disorder who also have identified liver disease. During Phase 1 of the study, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual) for 4 weeks. For the first week of Phase 2, patients will receive decreasing doses of TAU. During Phase 2, patients will take paliperidone ER in doses between 3 milligrams per day and 12 milligrams per day by mouth for 5 weeks.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Treatment as usual (TAU), Paliperidone ER	Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-09-26
• Last updated: 2014-07-25
• Results posted: 2013-09-20

Locations

21 sites across 1 country: United States